© 2017  Auk Technical Services

George Calafactor

BIOGRAPHY

 

George Calafactor is a 32-year food, cosmetic, drug, biologic, clinical, and medical device non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator and over 10 years of industrial experience as a biologic, pharmaceutical, and medical device industry quality assurance consultant, regulatory compliance specialist, and ASQ certified quality biomedical auditor. 

 

George’s educational background includes 2 BS degrees in Chemistry and Metallurgical Engineering from the University of Notre Dame, an MBA in International Business from Indiana University, and a MS in Regulatory Affairs for Drugs, Biologics, and Medical Devices with a concentration in Regulatory Compliance from Northeastern University.  As such, not only does George have vast internal working knowledge of FDA operations, but he also understands the need to balance industry business goals against external regulations, the linkages between the various quality system and clinical subsystems, and the struggles with quality, cultural, and business barriers to achieve sound quality systems. 

 

George not only has inspected, investigated, and audited all types of US and foreign food, cosmetic, drug, biologic, medical device, and clinical facilities, but has also performed various pharmaceutical and medical device quality assurance and regulatory compliance operations, such as monitoring and maintaining product and quality system failure investigations, non-conformances, complaints/ MDRs, and CAPAs, reconciling and analyzing numerous quality system data, writing and revising numerous top and mid-level written procedures, training various governmental and industry personnel in the areas of medical device quality, quality system, design control, and documentation and change control, and informing management and staff of current FDA and EU enforcement policies.    

 

George’s expertise is primarily in medical device quality assurance and regulatory compliance, and has vast knowledge utilizing US, European, Canadian, Australian, Brazilian, Japanese, and Chinese medical device quality system and clinical laws, regulations, standards, and guidelines. However, he is also familiar with and knows the similarities and differences between US food, human and animal pharmaceutical, cosmetic, biologic, tissue, and clinical laws, regulations, guidelines, and operations as well.

 

George is a self-starter with good written and oral communications skills and has a strong history and a proven record of accomplishment of leading or working with teams. George strives for continuous improvement, consistency in quality assurance and regulatory compliance with reduced waste while auditing, consulting, and contracting medical device, biologic, and pharmaceutical facilities.  George has participated in multiple projects to problem solve and has participated in and/or set up quality audit teams and wrote team reports while in the governmental and industrial capacities. In all projects, George has demonstrated hands on expertise. These skills have resulted in increased quality and operating integrity.

 

In addition, George is not the typical regulatory compliance and quality assurance expert.  Not only does George understand the inner workings of the FDA and regulated industry, but also international management operations.  George’s Myers-Briggs profile is also non-typical as well (i.e. ENFP).  These additional strengths have given George the necessary skills to multi-task, work as a team player, and be a leader, coach, and mentor while understanding the mechanisms of quality systems and the subsystem linkages balanced with the internal and external business constraints of clients.

 

Therefore, for over 32 years, George has successfully assisted numerous US and foreign companies to achieve quality and regulatory compliance, especially in the medical device arena. 

 

 

OBJECTIVE

To transition more than 32 years of professional experience from a government and an industry environment, into a consulting position utilizing my analytical, business, scientific, communication and creative skills in the non-technical quality assurance and regulatory compliance areas of domestic and international drug, biologic, and medical device realms.

 

BACKGROUND

I am an ASQ certified (QBA) medical device regulatory compliance and non-technical quality assurance expert, specializing in medical device quality systems. My career has been concentrating on US/ EU/ Canadian/ Australian/ Brazilian/ Japanese/ Chinese medical device auditing, investigating, compliance, and regulatory (except for preparing regulatory submissions). THUS, I AM NOT A QUALITY ENGINEER OR A REGULATORY AFFAIRS SPECIALIST; NOR HAVE I SET UP OR HOW TO PERFORM PROCESS VALIDATIONS, DESIGN PROJECTS, NOR HAVE WRITTEN ANY REGULATORY SUBMISSIONS (I.E. 510(K)'s, PMA's, TECHNICAL FILES, OR DESIGN DOSSIERS). However, I have audited and reviewed thousands of written procedures, quality records, quality system records, regulatory submissions, process validations, and design studies to see if they conform to external laws, directives, regulations, standards, and guidance, have seen all types of quality system and clinical operations, conducted gap analyses/ data reconciliations, and have given training and guidance to both governmental and industry personnel in these and other pharmaceutical, biologic, and medical device areas for over 31 years. I have also performed various hands-on non-technical quality assurance and regulatory compliance operations, such as preparing/ revising written procedures, preparing 21 CFR 803 baseline reports, conducting out of specification investigations, performing data reconciliations, and monitoring and maintaining complaints, non-conformances and CAPA's.  I am willing to take assignments anywhere worldwide and travel 100% (including internationally).

 

SUMMARY

A Self-starter with good written and oral communications skills and over 31 years of professional experience as a level II certified international medical device investigator in the US government or as a contract quality assurance consultant and regulatory compliance specialist in the medical device industry. I have a strong history and a proven track record of leading or working with the team in quality auditing of domestic and international class I/III medical device products, facilities and operations.  I strive for continuous improvement, and Consistent Quality Assurance with reduced waste while auditing, consulting, and contracting medical device facilities.  This includes auditing, reviewing, and critiquing all Validation/ Verification, protocol documentation, set up testing, build fixtures Define and Setup Quality Assurance programs and train personal (in-house, and/or contractors, local and offshore) while insuring a quality FDA QSR and/or ISO 9000-9003 certified build.  I have participated in multiple projects to problem solve while working in the government arena and as a medical device consultant. I have participated in and/or set up quality audit teams and wrote team reports while in the government or as a consultant. Audited, reviewed, and critiqued FMEA's, data and ongoing design considerations. In all audit and consulting projects, I have demonstrated hands on expertise. These skills have resulted in increased quality and operating integrity.

 
PROFILE

Medical Device quality assurance and regulatory compliance professional with more then 31 years of progressive experience. A diverse background in quality consulting, auditing, manufacturing, and pharmaceutical, biologic, and medical device operations, with vast experience in the medical device industry, internal FDA operations, and the international business arena.

 

SKILLS
  • Audit, review, and critique most lean related manufacturing technologies.

  • Perform regulatory compliance data reconciliations and documentation and change control and FDA listing operations.

  • Skilled in quality and business concepts, including quality systems and international business management.

  • Revise, prepare, audit, review and critique QA and QC programs and documentation to ensure quality production.

  • Provide QA Mfg. and test support for Mfg. floor and contract vendor production lines.

  • Provide information and support for ongoing product design and new product design review boards.

  • Audit, review and critique all QSM, SOP, EC, IQ, OQ, PQ, PPQ related protocols and documentation.

  • Audit, review and critique all QC Mfg. related protocols and documentation.

  • Audit, review and critique Risk Management program and deliverables (FMEA’s, FTA’s, etc.).

  • Audit, review and critique manufacturing program procedures, sampling, and processes.

  • Participate and represent Regulatory in Design and Manufacturing meetings. ECO, DRB, MRB, etc.

  • Knowledgeable in FDA, Health Canada, EU, Australian, Brazilian, Japanese, and Chinese medical device regulations.

  • Train and Qualify QA, Mfg., Test and Admin personnel related to the manufacturing and test processes.

  • Work with ISO/EN/CE, FDA, Health Canada, and other Agency documentation and Qualifications.

  • Revise, prepare, audit, review and critique Multi-level SOP, BOM, and ECO process instructions and records.

  • Audit, review and critique SPC and QC/QA related protocol and documentation.

  • Skilled in New Product Introduction (NPI) and CE mark certification processes.

  • Audit, review and critique validation SOPs and policies according to cGMPs for aseptic process validation, sterilization validation (steam, gamma, EtO, dry heat, chemical, etc.).

  • Audit, review and critique large and small subsidiaries and vendors for set-up and transfer of products to headquarters and vendor sites.

  • Audit, review and critique schematics, blueprints and build instructions for various medical devices, including in-vitro diagnostics, orthopedic, electrical and mechanical devices.

  • Audit, review and critique purchasing control records and operations and software and hardware validations.

  • Audit, review and critique Failure mode effect analysis of product design specifications and documentation.

  • Monitor, maintain, audit, review and critique Corrective action and process document processes.

  • Audit, review and critique Design review FMEAs and risk management for product design analysis.

  • Audit all major test equipment (such as scopes, logic analyzers, spectrum analyzers, etc.).

  • Audit all major production equipment (such as CNC machines, packaging machines, sterilizers, etc.).

 

REGULATORY EXPERTISE

All Types of Class I/III Medical Devices, Including Electronic, Mechanical, and Non-mechanical Medical Devices- Durable, Electronics, Implantables, IVDs, Lasers, Software, Cataract systems, Oncology systems, Coated Stents, Steerable Catheters, Over the wire (OTH), Rapid Exchange (RX) Stent delivery systems (STS), Pacemakers, Tracheostomy Tubes, Sterilized Devices, and Orthopedic Implants.   Adverse Event Evaluation, Audits -Certification/Due Diligence/ GCP/ GLP / ISO/Quality System Inspection Technique (QSIT)/ Quality System Regulation (QSR), Clinical Labeling / Research/ Study design, Electronic Records & Electronic Signatures; 21 CFR Part 11, FDA, FDA - 483 and Warning Letter Responses/Consent Decree, GMP, Hazard Analysis, ISO - 13485/ 9001/9002/ 9003/14971 (Risk Management)/ Active Implantable Medical Device Directive (AIMD) / In-vitro Diagnostic Directive/ Medical Device Directive (MDD), OSHA, Quality Assurance, Quality Control, Quality Management, Quality Systems Development/ Implementation, Working Knowledge of FDA Operations.

 

HIGHLIGHTS OF QUALIFICATIONS

•              Medical Device Compliance             ·  Results Oriented                              ·  Problem Resolution

•              Failure Modes & Effects Analysis   ·  Strong Negotiation Skills               ·  Strategic Planning

•              Excellent Communication Skills      ·  Team Player and Leader                ·  Project Management

 

 

 

EMPLOYMENT HISTORY

Independent (Temporary) Contract Positions

 

December 2016- Present      Farla Medical, London, UK

REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

Medical Device and Pharmaceutical/ Combination Product Own Label Product Distributor and Manufacturer: Farla Medical, London, UK

  • Determines FDA classification and regulatory scheme for various finished medical devices to be marketed in the US

  • Works with FDA Quality and Regulatory Consultants LLC (Cedar Park, TX) so that applicable 510(k)s, NDAs, and/or ANDAs can be submitted to the FDA for various class 2 medical devices, combination products, and pharmaceuticals

  • To register the company and list the applicable medical devices, combination products, and pharmaceuticals with the FDA via FURLS

  • To perform various regulatory compliance activities (such as performing a gap analysis of the company’s quality system) (to be conducted at a later date).

 

June 2016- Present            The CECON Group, Wilmington, DE

PRIMARY MEDICAL DEVICE REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

  • Provides technical consulting to corporate, legal and government clients.

  • Provides professional consulting as a Medical Device, Pharmaceutical, and Biologics Quality Systems Consultant.

Law Office (Confidential), Winchester, MA      April 2017- Present

  • Analyzes, investigates, and reviews court records, depositions and associated product labeling/ storage/ handling/ et al quality system documentation (including manufacturing company written procedures and quality data) pertaining to the improper storage and handling of medical device products and corresponding quality system procedures and quality records.

  • Additional activities to be determined at a later date.

Law Office (Confidential), Houston, TX      January 2017- Present

  • Analyzes, investigates, and reviews court records, depositions and associated CAR/ MDR/ complaint/ et al quality system documentation (including FDA MAUDE reports, 483’s, and warning letters and manufacturing company written procedures and quality data) pertaining to non-conforming medical device products and corresponding quality system procedures and quality records.

  • Additional activities to be determined at a later date.

Law Office (Confidential), North Haven, CT      June 2016- Present

  • Analyzes, investigates, and reviewes court records, depositions and associated CAR/ MDR/ complaint/ servicing, et al quality system documentation (including FDA 483’s, warning letters, and consent decrees) pertaining to non-conforming medical device products and corresponding quality system procedures and quality records.

  • Additional activities to be determined at a later date.

 

February 2016 – Present                  ComplianceIQ (aka ProForte), San-Bruno, CA

REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

  • Provides professional training and consulting to corporate, legal and government clients as a Medical Device Consultant when requested and as needed.

Webinar: Basics of Medical Device Document and Change Controls

July 2016

  • Provided online technical quality system training in the area of Medical Device Document and Change Controls to interested clients.

November 2015- December 2015  TSK Laboratory, Japan, Tochigi-Shi, Japan and Tochigo Seiko Co., Ltd., Tochigi-City, Japan

MEDICAL DEVICE REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

Medical Device Manufacturer: TSK Laboratory, Japan, Tochigi-Shi, Japan and Contract Manufacturer: Tochigo Seiko Co., Ltd., Tochigi-City, Japan

  • Supplied various medical device quality assurance and regulatory compliance guidance and assistance when requested.

  • Performed various reconciliation/ FDA readiness activities associated with upcoming FDA level II QSIT inspection.

  • Revised/ created quality system procedures using FDA laws, regulations, standards, and guidance documents.

  • Supplied various medical device quality assurance and regulatory compliance training, guidance and assistance when requested.

  • Trained company engineering, production, and regulatory/quality department personnel in various medical device quality, regulatory compliance, and quality system requirements (including FDA and EU laws, directives, regulations, and standards, design controls, CAPA system, document and change controls, and facility and material controls)

  • Performed mock FDA level II QSIT Audit per FDA laws, regulations, standards, and guidance documents.

  • Assisted with various FDA readiness activities, including overseeing QSIT subsystem teams, facility revisions, and procedural and document revisions.

  • Assisted in various FDA inspection backroom activities (including subject matter expert coaching).

 

October 2015- Present      SkillsAlliance, London, UK

MEDICAL DEVICE REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

  • Provides technical consulting to corporate, legal and government clients.

  • Provides professional consulting as a Medical Device, Pharmaceutical, and Biologics Quality Systems Consultant.

Medical Device Manufacturer and Contract Manufacturer: TSK Laboratory, Japan, Tochigi-Shi, Japan and Tochigo Seiko Co., Ltd., Tochigi-City, Japan

October 2015

  • Performed various reconciliation/ FDA readiness activities associated with upcoming FDA level II QSIT inspection.

  • Revised/ created quality system procedures using FDA laws, regulations, standards, and guidance documents.

  • Supplied various medical device quality assurance and regulatory compliance training, guidance and assistance when requested.

  • Trained company engineering, production, and regulatory/quality department personnel in various medical device quality, regulatory compliance, and quality system requirements (including FDA and EU laws, directives, regulations, and standards, design controls, CAPA system, and document and change controls)

  • Performed mock FDA level II QSIT Audit per FDA laws, regulations, standards, and guidance documents.

 

August 2015 – Present                      Compliance2Go, Houston, TX

REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

  • Provides professional training and consulting to corporate, legal and government clients as a Medical Device Consultant when requested and as needed.

Webinar: Medical Device Quality, Quality Systems, and Regulatory Compliance

August 2016

  • Provided online technical quality system training in the area of Medical Device Quality, Quality Systems, and Regulatory Compliance to interested clients.

 

April 2015- Present           Neozene, Inc., Oakland, CA

PRIMARY MEDICAL DEVICE REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

  • Provides technical consulting to corporate, legal and government clients.

  • Provides professional consulting as a Medical Device, Pharmaceutical, and Biologics Quality Systems Consultant.

Medical Device Manufacturer: Varian Medical Systems, Winnipeg, Manitoba, Canada

April 2015

  • Revised purchasing control/ supplier audit quality system procedures using FDA, Health Canada, and EU laws, regulations, directives, standards, and guidance documents.

 

April 2015 – Present                         ComplyArena, Exton, PA

REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

  • Provides professional training and consulting to corporate, legal and government clients as a Medical Device Consultant when requested and as needed.

Webinar: Corrective Actions And Preventive Action (CAPA) And How To Initiate, Handle, Monitor And Manage? April 2015

  • Provided online technical quality system training in the area of Medical Device CAPA system to interested clients.

Webinar: Medical Device Design Controls: How to Handle, Monitor and Manage

June 2015

  • Provided online technical quality system training in the area of Medical Device design controls to interested clients.

 

March 2014- Present                         Ivy Tech Community College, Warsaw, IN

REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

  • Provides technical and professional training to corporate, legal and government clients as a Medical Device Consultant when requested and as needed.

               Classroom training: Orthopedic Quality Standards and Technical Skills Certificate Program

March 2014

  • Provided technical and professional FDA QSR and ISO 13485 Quality System training to interested personnel.

 

February 2014 – Present                  Compliance Online, Palo Alto, CA

REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

  • Provides professional training and consulting to corporate, legal and government clients as a Medical Device Consultant when requested and as needed.

               Webinar: Basic Medical Device CAPA (Corrective Action and Preventive Action) System Concepts

February 2014

  • Provided online technical quality system training in the area of Medical Device CAPA system to interested clients.

 

January 2014- Present      Adecco Staffing, Indianapolis, IN

CONTRACT MEDICAL DEVICE QUALITY ASSURANCE AND REGULATORY COMPLIANCE EXPERT

  • Provides technical consulting to corporate, legal and government clients.

  • Provides professional consulting as a Medical Device, Pharmaceutical, and Biologics Quality Systems Consultant.

Medical Device Manufacturer: Zimmer USA, Warsaw, IN

January 2014

  • Reconciled medical device design history files using FDA laws, regulations, and guidance documents.

 

November 2013          Signature Orthopaedics Pty, Sydney, Australia

CONTRACT MEDICAL DEVICE QUALITY ASSURANCE AND REGULATORY COMPLIANCE EXPERT

  • Supplied various medical device quality assurance and regulatory compliance guidance and assistance when requested.

  • Provided import training to various site personnel (online training via GO-TO-MEETING).

 

October 2013- Present      Regulatory Compliance Associates, Inc.,    Pleasant Prairie, WI

REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

  • Provides technical consulting to corporate, legal and government clients.

  • Provides professional consulting as a Medical Device, Pharmaceutical, and Biologics Quality Systems Consultant.

Medical Device Manufacturer: Ad-Tech Medical Instrument Corporation, Racine, WI

October 2013

  • Conducted quality plan reconciliation and improvement using FDA laws, regulations, and guidance documents.

 

August 2013 - Present       Validant, Inc., San Francisco, CA

REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

  • Provides technical consulting to corporate, legal and government clients when requested and as needed.

  • Provides professional consulting as a Medical Device, Pharmaceutical, and Biologics Quality Systems Consultant when requested and as needed.

                Medical Device Manufacturer: EKOS, Inc., Bothell, WA

September 2013

  • Conducted external mock FDA QSIT inspection using FDA laws, regulations, and guidance documents.

August 2013 – September 2013     Compliance Architects, Robbinsville, NJ

CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

  • Provided professional auditing as a contract Medical Device Quality Systems Auditor.

               Contract Medical Device Manufacturer: Medicia, Dayton, NJ

September 2013

  • Conducted external mock FDA QSIT inspection using FDA laws, regulations, and guidance documents.

 

June 2013 – Present          PSC Creative Learning, Pomona, CA

REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

  • Provides technical training & professional consulting to corporate, legal and government clients as a Medical Device Consultant when requested and as needed.

               Webinar: Understanding and Performing Medical Device Internal and External Quality Audits (Parts 1 & 2)

June & July 2013

  • Provided online technical quality system training in the area of 1st, 2nd, & 3rd Party Quality Audits to interested clients.

 

June 2013 - Present           AUK Technical Services LLC, Beverly Hills, CA

QUALITY DIRECTOR

  • Provides technical consulting to corporate, legal and government clients when requested and as needed.

  • Provides professional consulting as a Medical Device, Pharmaceutical, Biologics, Food, and Tobacco Products GMP/ Quality Systems Consultant when requested and as needed.

Medical Device Manufacturer: Abbott Laboratories/ St. Jude Medical, Atlanta, GA

March 2017

  • Performed corporate audit of acquired PMA medical device product under FDA and international laws, regulations, directives, standards, guidance, and the QSIT manual.

Medical Device Manufacturer: Aroa Biosurgery, Aukland, NZ

January-February 2017

  • Performed desk-audit of device- biologic combination products’ risk documentation against FDA laws and regulations and QSIT manual.

Medical Device Specification Developer: Ultroid Technologies, Inc., Tampa, FL (relocated at Hudson, MI on August 2016) (Out of Business October 2016)

February 2016- September 2016

  • Worked with other AUK Technical Services team members to assist with Warning Letter reconciliation of a medical device specification developer, including creating quality system procedures, issuing CAPAs, and drafting a Warning Letter reply to the FDA (all performed remotely from residence).

  • Oversaw and performed 21 CFR 806 product removal operations.

    • Prepared draft 21 CFR 806 product removal report to the FDA.

    • Trained and worked with temporary workers in the creation of product/ customer removal list for the FDA.

  • Acted as Quality and Regulatory Manager/ Management Representative from August 2016- September 2016 (performed remotely at residence and at Hudson, MI).

  • Managed product destruction operations at Hudson, MI (September 2016).

    • Trained and worked with temporary workers on the identification, nonconformance, storage, and handling of onsite non-conforming products and behavior during FDA inspections and investigations (with the product destruction to be witnessed by the FDA at a later time).

    • Prepared and/or oversaw the preparation of nonconforming product records by temporary workers associated with the onsite nonconforming products.

    • Prepared destruction written procedures and trained temporary workers on non-conforming product, product destruction, and good documentation practice operations and written procedures.

    • Liason between top management and FDA during FDA inspection of destroyed products.

E-cigarette Consulting Company: Chemular Inc., Hudson, MI (New U.S. Company)

June 2016- Present

  • Works with other AUK Technical Services team members (as contractors and employees for Chemular, Inc.) to assist getting US and foreign e-cigarette clients in compliance with FDA and EU tobacco regulations.

Medical Device Contract Manufacturer: Hudson Scientific LLC, Hudson, MI (New U.S. Company)

February 2015- October 2016, May 2017- Present

  • Performs various regulatory compliance and quality assurance work and assists onsite staff as needed and required.

  • Worked(s) with other AUK Technical Services team members and temporary workers to assist with start-up of a medical device/ combination product company so that company is in compliance with FDA laws and regulations.

    • Oversaw and performed the creation of draft quality system procedures.

    • Advised company engineering and production department personnel in FDA medical device, pharmaceutical, and combination product requirements.

  • Trained(s) company engineering, production, and quality department personnel in various medical device quality, regulatory compliance, and quality system requirements (including FDA and EU laws, directives, regulations, and standards, design controls, CAPA system, and document and change controls).

  • Acted as Quality and Regulatory Manager/ Management Representative from September 2016- October 2016 (performed remotely at residence and at Hudson, MI).

Food Manufacturer: Fong Kee Tofu Company, Inc., San Francisco, CA

February 2015

  • Performed follow-up consent decree audit to assess compliance against 21 CFR 110 (Food GMPs).

Foreign Medical Device Specification Developer/ Repacker/ Relabeler: Tanda Beauty, Cambridge, Ontario, Canada

May 2014

  • Headed and overseen all back-room activities during an initial FDA QSIT inspection at site.

  • Conducted production, facility, and quality system procedural and quality record examinations and reviews using FDA laws, regulations, and guidance documents.

  • Performed and assisted with applicable regulatory compliance and quality assurance activities as required, including complaint and MDR guidance, and external audit finding corrections.

  • Provided regulatory and compliance expertise to top management and quality and operational departments, including FDA inspectional and compliance operations.

Medical Device Manufacturer: Philips Medical Systems (Cleveland) Inc., Cleveland, OH

April 2014- June 2014

  • Performed offsite desk-audit review design control, risk management, and automated process quality system procedures using FDA laws, regulations, and guidance documents.

  • Assisted 3rd Party audit team with final audit report write-up and guidance (performed offsite).

Contract Medical Device Specification Developer: EPRT Technologies, Inc., Simi Valley, CA

June 2013

  • Conducted internal and external auditing using EU and FDA laws, directives, regulations, and standards.

 

May 2013 – July 2013      FXI, Inc., Media, PA

CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

  • Provided technical and professional consulting to corporate and site management and staff as a Medical Device Consultant.

  • Performed applicable regulatory compliance and quality assurance activities as required.

               Contract Medical Device Manufacturer: Joerns Healthcare, Berwyn, MS

July 2013

  • Conducted gap analysis (desk audit) and onsite supplier audit using FDA laws, regulations, and guidance documents.

  • Provided regulatory and compliance expertise to top management and quality and operational departments.

 

April 2013 - Present          FDA Quality and Regulatory Consultants LLC, Cedar Park, TX

CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

  • Provides technical consulting to corporate, legal and government clients when requested and as needed.

  • Provides professional consulting as a Medical Device, Pharmaceutical, and Biologics Quality Systems Consultant when requested and as needed.

               Contract Medical Device Manufacturer: Apical Inc., Simi Valley, CA

July 2013

  • Conducted mock FDA pre- PMA supplier audit using FDA laws, directives, regulations, and standards.

  • Performed applicable regulatory compliance and quality assurance activities as required.

  • Provided regulatory and compliance expertise to top management and quality and operational departments.

              Combination Drug/Medical Device Foreign Manufacturer: Sanofi Pasteur, Frankfurt, Germany

May-2013

  • Conducted mock FDA combination product pharmaceutical/ medical device preapproval audit using FDA medical device laws, directives, regulations, and standards.

  • Performed applicable regulatory compliance and quality assurance activities as required.

  • Provided regulatory and compliance expertise to top management and quality and operational departments.

 

April 2013 – Present         Quality Engineering Consultants LLC, Minneapolis, MN

CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

  • Provides technical consulting to corporate, legal and government clients.

  • Provides professional consulting as a Medical Device, Pharmaceutical, and Biologics Quality Systems Consultant.

               Medical Device Specification Developer: Nextremity Solutions, Inc., Warsaw, IN

November 2015

  • Conducted internal audit using FDA QSR and ISO 13485 standard.

Pharmaceutical Package Manufacturer: Drug Plastics & Glass Co., Kittanning, PA

June 2013

  • Conducted supplier audit using FDA pharmaceutical laws and regulations.

              Medical Device Design Controls Translation Company: Excel Translations, Pittsburgh, PA

June 2013

  • Conducted internal audit using ISO 13485 standard.

 

January 2013- Present                      Oriel STAT-A-MATRIX, Edison, NJ

CONTRACT SENIOR MANAGEMENT CONSULTANT

  • Provides quality system and technical training and consulting to corporate, legal and government clients when requested and as needed.

  • Provides professional training and consulting as a Medical Device Consultant when requested and as needed.

  • Revises and updated applicable medical device training presentations.

Training Preparation: EU MDR/ IVDR course

February- March 2017

  • Prepared training materials of a new OSAM course.

Medical Device Manufacturer: Beckman Coulter, Miami, FL

July 2015

  • Provided technical advanced quality system training in the area of CAPA system (including 21 CFR 803, 806, and 820.90, 100, 198, 200, and 250) to management and quality, regulatory, and operational personnel.

Medical Device/ Combination Product Manufacturer: MedInstill, New Milford, CT (New U.S. Company)

February 2015

  • Developed implementation plan and various quality system procedures.

Onsite Training: Design Control Concepts & Risk Management Concepts (U.S. Medical Device Manufacturer) MedImmune, Inc., Gaithersburg, MD

December 2014

  • Provided technical quality system training in the area of Medical Device Design Controls to new company employees.

Medical Device Manufacturer: Midmark Corporation, Versailles, OH

July 2014

  • Assisted in FDA 483/ Warning Letter/ QSR reconciliation activities pertaining to the complaint handling operations.

Public Training: Supplier Quality Management: Designing and Implementing a Successful Program

July 2014, Edison, NJ

  • Provided technical quality system training in the area of Medical Device Purchasing Controls to interested clients.

Public Training: Risk Management and Analysis for Medical Devices

June 2014, San Francisco, CA

  • Provided technical quality system training in the area of Medical Device Risk Management to interested clients.

Public Training: Design Control Concepts and Implementation, San Francisco, CA

June 2014

  • Provided technical quality system training in the area of Medical Device Design Controls to interested clients.

Public Training: 510(k) Process for Medical Devices and CE Marking, EU Directives, and Guidance Documents, San Diego, CA

January 2013

  • Provided technical regulatory compliance training in the areas of US FDA and European Medical Device regulatory compliance basics to interested clients.

 

December 2012- April 2013            Accurate Consultants, Inc., San Diego, CA

CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

  • Provided technical consulting to corporate, legal and government clients.

  • Provided professional consulting as a Medical Device, Pharmaceutical, and Biologics Quality Systems Consultant.

               Medical Device Initial Importer, Installer, and Servicer: Surehands Lift & Care Systems, Pine Island, NY

April 2013

  • Conducted QSR audit of complaint, MDR, installation, and servicing operations using FDA laws and regulations.

  • Provided regulatory and compliance expertise to top management and quality and operational departments.

Medical Device Manufacturer: Signature Orthopaedics Pty, Sydney, Australia

February 2013- March 2013

  • Conducted QSR audit using FDA laws, regulations, and guidance documents.

  • Provided regulatory and compliance expertise to top management and quality and operational departments.

Medical Device Initial Importer: GM Scientific LLC, Lake Forest, IL

January 2013- February 2013

  • Conducted QSR audit of complaint and MDR operations using FDA laws, regulations, and guidance documents.

  • Provided regulatory and compliance expertise to top management and quality and operational departments.

 

December 2012  Compliance Gurus, Inc., West Newbury, MA

CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

  • Provided technical consulting to corporate, legal and government clients.

  • Provided professional consulting as a Medical Device, Pharmaceutical, and Biologics Quality Systems Consultant.

               Medical Device Manufacturer: Sibex Inc., Crystal River, FL

December 2012

  • Conducted QSR audit using FDA laws, regulations, and guidance documents.

  • Provided regulatory and compliance expertise to top management and quality and operational departments.

 

November 2012- Present                  ProPharma Group, Overland Park, KS

CONTRACT MEDICAL DEVICE REGULATORY COMPLIANCE CONSULTANT

  • Provides quality system and technical training and consulting to corporate, legal and government clients when requested and as needed.

  • Provides professional training and consulting as a Medical Device Consultant when requested and as needed.

Medical Device Manufacturer: Staar Surgical, Monrovia, CA

August 2014

  • Conducted internal audit of medical device quality management system using FDA and various international laws, regulations, directives, standards, and guidance documents.

  • Assisted in FDA 483/ Warning Letter/ QSR reconciliation activities and/or various regulatory compliance quality management system improvement activities as needed.

 

October 2012- Present      Compliance Insight, Inc., Fairfield, OH 45014

CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

  • Provides technical consulting to corporate, legal and government clients when requested and as needed.

  • Provides professional consulting as a Medical Device, Pharmaceutical, and Biologics Quality Systems Consultant when requested and as needed.

               Medical Device Initial Importer: Aniara Diagnostica, LLC, West Chester, OH

October 2012

  • Conducted QSR audit using FDA laws, regulations, and guidance documents.

  • Provided regulatory and compliance expertise to top management and quality and operational departments.

 

September 2012- Present                Azzur Group Willow Grove, PA

CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

  • Provided technical consulting to corporate, legal and government clients.

  • Provided professional consulting as a Medical Device, Pharmaceutical, and Biologics Quality Systems Consultant.

Various Foreign Medical Device Manufacturers: Depuy-Synthes, Various cities, Switzerland

November 2016-January 2017       

  • To perform internal auditing activities of quality system using FDA & various international medical device laws, regulations, standards, directives, and guidance documents.

               Pharmaceutical Manufacturer: McNeil, Fort Washington, PA

October 2012     

  • Performed corporate confirmation, verification, and auditing activities against an FDA consent decree for a MNC subsidiary pharmaceutical company.

  • Provided regulatory and compliance expertise to top management and parent regulatory compliance and subsidiary company departments.

 

August 2012- December 2015        enKap, West Palm Beach, FL (Out of Business as of December 2015)

MEDICAL DEVICE REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

  • Provided professional and technical training and procedures to corporate, legal and government clients as a Consultant.

 

 

May 2012- March 2013   Pathwise, American Fork, UT

CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

  • Provided technical consulting to corporate, legal and government clients.

  • Provided professional consulting as a Medical Device, Pharmaceutical, and Biologics Quality Systems Consultant.

               Medical Device Manufacturer/ Contract Manufacturer:  Ora Tech, South Jordan, UT

March 2013        

  • Conducted IVDD/ MDD/ISO 13485/ QSR audit of quality assurance, regulatory, and design control operations using FDA laws, regulations, and guidance documents.

  • Provides regulatory and compliance expertise to top management and quality departments.

              Medical Device Specification Developer/ Manufacturer:  Acon Laboratories, San Diego, CA

May 2012            

  • Conducted IVDD/ MDD/ISO 13485/ QSR audit of quality assurance, regulatory, and design control operations using FDA laws, regulations, and guidance documents.

  • Provides regulatory and compliance expertise to top management and quality departments.

               Medical Device Contract Manufacturer: Helix Medical, LLC, Baldwin Park, CA

July 2012- September 2012              

  • Conducted MDD/ISO 13485/ QSR gap analysis of documentation and change controls, training, CAPA, process validation, and design control operations and prepared an action plan to correct the identified gaps.

  • Provided regulatory and compliance expertise to top management and quality and engineering departments.

  • Conducted internal audits of the quality system and prepared gap analysis correction plan.

  • Assisted with the improvement of quality control procedures and SOPs as required.

  • Assisted with training sessions related to regulatory, compliance, quality, and auditing to top management, and to the quality, engineering/R&D, and production departments.

 

March 2012                 Electrika, Inc., Islip Terrance, NY & Somatics, LLC, Lake Bluff, IL

CONTRACT MEDICAL DEVICE QUALITY EXPERT

  • Assisted with the correction to FDA 483 observations of the specification developer.

  • Conducted gap analysis of quality system of contract manufacturer using FDA laws, regulations, and guidance documents.

  • Assisted with the improvement of quality control procedures and SOPs as required.

  • Provided regulatory, quality, and technical expertise to the top management.

  • Conducted desk audit of the quality system of the contract manufacturer.

  • Prepared written audit correction plan.

  • Performed various audit correction activities, including revising written instructions, revamping the management control, document and change control, quality auditing, purchasing control, CAPA, and production and process control operations.

 

July 2011- Present             Pan America Hyperbarics, Inc. (PAHI), Richardson, TX and Kaohsiung, Taiwan (CHINA)

CONTRACT MEDICAL DEVICE QUALITY ASSURANCE AND REGULATORY COMPLIANCE EXPERT

  • Supplies various medical device quality assurance and regulatory compliance guidance and assistance when requested.

 

June 2010            ADB Consulting & CRO, Inc., Pembroke Pines, FL

CONTRACT MEDICAL DEVICE QUALITY SYSTEMS EXPERT

  • Provided technical consulting to corporate, legal and government clients.

  • Provided professional consulting as a FDA Medical Device Quality Systems Consultant.

               Medical Device GLP Laboratory: BioSurg, Inc., Winters, CA

June 2010           

  • Conducted gap analysis and initial qualification of GLP facility for USA Sponsor-Monitor of IDE medical device using FDA laws and regulations.

  • Provided regulatory and compliance expertise to top management and quality departments.

 

February 2010- May 2010           Pan America Hyperbarics, Inc., Kaohsiung, Taiwan (CHINA)

CONTRACT MEDICAL DEVICE QUALITY EXPERT

  • Conducted gap analysis of quality system using FDA laws, regulations, and guidance documents.

  • Assisted with the development of quality control procedures and SOPs as required.

  • Provided regulatory, quality, and technical expertise to the top management and quality, R&D, and production departments.

  • Conducted training sessions related to regulatory, compliance, quality, and auditing to top management, and to the quality, engineering/R&D, and production departments.

  • Conducted internal audits of the quality system and prepared written audit correction plan.

  • Performed various audit correction activities, including giving QSR training, revising written instructions, and revamping the document and change control, purchasing control, CAPA system, and production and process control systems.

 

March 2009- May 2014                 The FDA Group, Worchester, MA

CONTRACT MEDICAL DEVICE QUALITY EXPERT

  • Provided technical consulting to corporate, legal and government clients.

  • Provided professional consulting as a FDA Medical Device Quality Systems Consultant.

Device Manufacturer: Nevro Medical, Menlo Park, CA

May 2014

  • Conducted gap analysis and various internal and supplier audits of quality system using FDA laws, regulations, and guidance documents.

Combination Product Manufacturer: AcelRx; Contract Device Manufacturer: Hunter Technologies, Milpitas, CA

April 2014- May 2014

  • Conducted Mock FDA PAI audit of contract manufacturer’s quality system using FDA laws, regulations, and guidance documents.

Device Manufacturer: Atrium Medical, Hudson, NH

March 2014

  • Conducted gap analysis and internal audits of quality system using FDA laws, regulations, and guidance documents.

  • Assisted with the development of quality control procedures and SOPs as required.

  • Provided regulatory, quality, and technical expertise to the top management, quality, R&D, and operational departments.

Device Manufacturer: Thermo Fisher Scientific, Middletown, MA

March 2010

  • Provided guidance of off label requirements using FDA laws and regulations.

       Device Manufacturer: Pan America Hyperbarics, Inc., Kaohsiung, Taiwan (CHINA)

January 2010

  • Conducted gap analysis and internal audits of quality system using FDA laws, regulations, and guidance documents.

  • Assists with the development of quality control procedures and SOPs as required.

  • Provided regulatory, quality, and technical expertise to the top management and quality, engineering/R&D, and production departments.

  • Conducted training sessions related to regulatory, compliance, quality, and auditing to top management, and to the quality, engineering/R&D, and production departments.

         Pharmaceutical, Biologic, and Medical Device Specification Developer: Healthpoint, Ltd., Fort Worth, TX

         May 2009           

  • Conducted gap analysis of quality system written procedures using FDA and EU laws, standards, and regulations.

         Initial Importer/ Distributor and Contract Medical Device Manufacturer (Installer and Servicer):

         Pan America Hyperbarics, Inc. Richardson, TX

         December 2009

  • Conducted gap analysis and internal audits of quality system using FDA laws, regulations, and guidance documents.

  • Assisted with the development of quality control procedures and SOPs as required.

  • Provided regulatory, quality, and technical expertise to top management, quality, & installation/ servicing departments.

  • Conducted training sessions related to regulatory, compliance, quality, and auditing to top management, and to the quality and installation/ servicing departments.

 

December 2009           Orchid Design, Shelton, CT

CONTRACT MEDICAL DEVICE QUALITY EXPERT

  • Provided technical consulting to corporate, legal and government clients.

  • Provided professional consulting as a FDA Medical Device Quality Systems Consultant.

               Medical Device Client: Mini-Lap Technologies, Inc. Dobbs Ferry, NY

December 2009              

  • Conducted gap analysis of quality system written procedures using FDA and EU laws, directives, regulations, standards, and guidance documents.

 

November 2009- Present       Gerson Lehrman Group, New York, NY

CONTRACT MEDICAL DEVICE QUALITY EXPERT

  • Provided technical consulting to corporate, legal and government clients.

  • Provided professional consulting as a FDA Medical Device Quality Systems Consultant.

Medical Device Client: Confidential Investment Company, New York, NY

March 2014

  • Discussed Medical Device QSR (concentrating on P&PC subsystem and linkages) and FDA regulatory operations for various sizes and types of Medical Device Manufacturers and Contract Manufacturers.

 

 

 

Medical Device Client: Confidential Investment Company, UK

March 2014

  • Discussed Medical Device QSR, FDA regulatory operations and compliance trends for various sizes and types of Medical Device Manufacturers and Contract Manufacturers.

Medical Device Client: Confidential Investment Company, UK

March 2014

  • Discussed Medical Device QSR and FDA regulatory operations, and organizational structures for various sizes and types of Medical Device Manufacturers and Contract Manufacturers.

Medical Device Client: Confidential Investment Company, UK

December 2013              

  • Discussed Medical Device QSR and FDA regulatory operations for US Orthopedic Medical Device Contractors.

               Medical Device Client: Confidential Medical Device Manufacturer, New York, NY

               November 2009             

  • Analyzed business, legal, quality, sterilization and non-conformance data associated with orthopedic implant MDR claims made by another orthopedic implant competitor.

May 2009- August 2009                Engineering Resource Group, Morris Plains, NJ

CONTRACT MEDICAL DEVICE QUALITY EXPERT/ QUALITY CONSULTANT

  • Provided quality compliance consulting and contracting to corporate, clients.

Contract Medical Device Manufacturer: Medin, Corp, Passaic, NJ

May 2009- August 2009       

  • Conducted gap analysis of quality system using FDA and EU laws, regulations, directives, standards, and guidance documents.

  • Assisted with the development of quality control procedures and SOPs as required.

  • Ensured product development follows appropriate design control requirements.

  • Provided regulatory, quality, and technical expertise to the engineering, quality, and production departments.

  • Conducted training sessions related to regulatory, compliance, quality, and auditing for top management, and to the engineering, quality, and production departments.

  • Conducted internal audits of the quality system.

  • Developed various regulatory, quality and compliance logs and spreadsheets.

  • Assisted the quality engineer in various quality compliance activities, as needed.

 

June 2008- February 2009           Aerotek Scientific, LLC, Piscataway, NJ

CONTRACT MEDICAL DEVICE CONSULTANT/ REGULATORY SPECIALIST

  • Provided quality compliance consulting and contracting to corporate, clients.

Dental Medical Device/ Pharmaceutical Manufacturer: Sultan Healthcare, Englewood/ Hackensack, NJ     

June 2008- February 2009              

  • Conducted mock/internal/external FDA/ISO/MDD QSR audits of domestic manufacturing facilities within the medical device realm.

  • Provided technical support, and regulations and standards support to the audit team.

  • Performed in-depth process audits and data analyses, as required.

  • Ensured corrective actions are effective in addressing the root cause to help prevent the recurrence of non-conformities.

  • Performed statistical analysis such as process capability, trend analysis and process control

  • Issue, as required, corrective action and preventive action on the processes

  • Completed technical reviews and analyses of nonconformities, corrective actions and preventive actions (CAPA’s), and complaints as required. Prepare CAPA analyses and issue corresponding CAPA’s.

  • Functioned as the back-up to the QA/RA Manager for review and approval purposes

  • Maintained technical files and risk management files for all devices and pharmaceuticals.  Responsible for organizing and scheduling periodic risk management reviews.

  • Responsible for filing product registration applications and handling government interactions pertaining to the regulation process for registering products in the EU, Japan, Australia and Canada, when requested.

  • Interfaced with customers, regulatory bodies (FDA, TUV, Health Canada) as required.

  • Reviewed, analyzed, and communicated the effectiveness of Corrective and Preventive actions.

  • Reviewed and provided QA technical support of ECN’s and label content for regulatory requirements. 

  • Reviewed and approved manufacturing instructions, product and packaging specifications and provide technical assistance.

  • Promoted and supported continuous improvement initiatives.

  • Assured compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and ISO regulatory requirements.

 

 

Permanent Regulatory Compliance Positions

 

July 2010 – May 2012       Biomet, Inc., Warsaw, IN

REGULATORY COMPLIANCE SPECIALIST

  • Conducted mock/internal/external FDA QSR, product, and process audits and investigations of domestic manufacturing facilities of Biomet, including corporate audits of subsidiaries and divisions, within the medical device, pharmaceutical, biologics, and tissue realms.

  • Completed quality records and/or prepares written procedures (such as pertaining to design control, servicing, and document and change control written procedures and CAPA reports) when needed or requested.

  • Performs various regulatory compliance activities (such as ‘hands-on’ document and change control administrative activities, FDA product listing activities, and transfer plan reconciliations).

  • Headed or assisted with various regulatory compliance and quality projects (such as improving the design control, document and change control and internal audit programs).

  • Evaluated product designs and manufacturing processes for compliance with regulations.

  • Performed onsite reviews of firm written procedures, processes, and operations and where necessary, recommended corrections for continuous improvement.

  • Established continuous process improvement at various levels at the organization (such as reconciling product registration, listing, and submission data and preparing various quality and regulatory training presentations).

  • Extensive background in the enforcement of consumer protection regulations.

  • Thorough knowledge of all provisions of the Federal Food, Drug, and Cosmetic (FD&C) Act.

  • Experience in both the FDA field and headquarters offices to ensure compliance prior to FDA inspectional visits. 

  • Knowledge of Medical Device Directives, ISO 13485:2003, Canadian Medical Device Regulations, Japanese Medical Device Regulations, Brazilian Medical Device Regulations, and Chinese Medical Device Regulations.

  • Ensured that manufacturers’ employees have proper knowledge of applicable regulations.

  • Developed and implemented business practices improving and reducing operating expenses of company sites (such as supplying solutions to correct any internal and external quality system deviations and preparing various quality system training presentations for future training sessions).

  • Collaborated with site manufacturing personnel to gather information and explain findings.

  • Advised firm officials on current FDA & EU enforcement policies.

  • Conducted informal training sessions on quality, medical device regulations, FD&C law, inspection and investigation techniques and other related topics.

  • Communicated with and maintained customer relations with personnel (such as during internal audits of other site locations).

  • Significant experience in making group presentations to firm officials and personnel.

 

January 2008 – April 2008          Synthes, USA, West Chester, PA

REGULATORY COMPLIANCE AUDITOR

  • Conducted mock/internal/external FDA QSR audits of domestic and foreign manufacturing facilities of Synthes, including supplier audits, within the medical device realm and advised firm officials on FDA enforcement policies.

  • Completed quality records and/or prepared written procedures (such as pertaining to CAPA validation/verification of effectiveness reports) when requested.

  • Evaluated product designs and manufacturing processes for compliance with regulations.

  • Performed onsite reviews of firm written procedures, processes, and operations and where necessary, recommended corrections for continuous improvement.

  • Established continuous process improvement at various levels at the organization.

  • Extensive background in the enforcement of consumer protection regulations.

  • Thorough knowledge of all provisions of the Federal Food, Drug, and Cosmetic Act.

  • Experience in both the FDA field and headquarters offices to ensure compliance prior to FDA inspectional visits.

  • Ensured that manufacturers’ employees have proper knowledge of applicable regulations.

  • Developed and implemented business practices improving and reducing operating expenses of company sites (such as aiding in the creation of new device master records).

  • Collaborated with site manufacturing personnel to gather information and explain findings.

  • Conducted training sessions on inspection and investigation techniques and other related topics.

  • Communicated with and maintained customer relations with facility personnel (such as during internal audits of other sites).

 

 

 

 

 

 

 

January 1985- February 2006       US Food and Drug Administration, Chicago, IL/ Pittsburgh, PA/ South Bend, IN

ANALYST/LEVEL II CERTIFIED INTERNATIONAL MEDICAL DEVICE INVESTIGATOR

  • Analyzed FDA-regulated food, cosmetic, and pharmaceutical products for compliance against FDA laws and regulations, including AOAC and USP/NF requirements.

  • Conducted routine inspections of domestic and foreign manufacturing facilities and investigated consumer complaints related to FDA-regulated products, primarily within the medical device industry.

  • Conducted full foreign medical device inspections for over 10 years at sites manufacturing all classes and types of medical devices and located throughout Canada and Europe.

  • Evaluated product designs and manufacturing processes for compliance with regulations.

  • Performed and documented numerous inspections, achieving enhanced compliance through various regulatory actions including warning letters and seizures.

  • Established continuous process improvement at all levels in organization.

  • Extensive background in the enforcement of consumer protection regulations.

  • Thorough knowledge of all provisions of the Federal Food, Drug, and Cosmetic Act.

  • Experience in both the field ensuring FDA compliance as well as in the headquarters office.

  • Worked (internal detail positions) as a field compliance officer, FDA HQ international medical device inspection planner, and FDA HQ International compliance officer.

  • Ensured that manufacturers’ employees have proper knowledge of applicable regulations.

  • Developed and implemented business practices improving and reducing operating expenses.

  • Collaborated with manufacturers’ personnel to gather information and explain findings.

  • Initiated legal actions against violators.

  • Advised industry, state, and local officials and consumers on enforcement policies.

  • Conducted training sessions on inspection and investigation techniques and other related topics.

  • Communicated with and maintained customer relations.

  • Served as team leader on complex assignments requiring the participation of multiple personnel.

  • Fulfilled the duties of the Resident-In-Charge during an extended period of absence.

  • Significant experience in making group presentations.

  • Demonstrated skills in preparing comprehensive and easily understood written communications.

  • Fostered team spirit and open communication on all phases of business.

  • Developed approaches and procedures, which have improved the efficiency of agency operations.

  • Level I/II Certified International Medical Device Investigator.

  • Detroit District Medical Device Co-Leader – Indiana, 1998-2000.

  • Detroit District Medical Device Team Leader, 1996-1997.

 

 

EDUCATION AND TRAINING

2015- 2017: Master of Science, Regulatory Affairs for Drugs, Biologics, and Medical Devices, Concentration in Regulatory Compliance (High Honors), Northeastern University, Boston, MA

2010: ASQ Certified Quality Biomedical Auditor (QBA)

1991-1999: Master of Business Administration, Concentration in International Business, Indiana University, South Bend, IN

1984-1989: Bachelor of Science, Metallurgical Engineering, University of Notre Dame, Notre Dame, IN

1978-1982: Bachelor of Science, Chemistry, University of Notre Dame, Notre Dame, IN

 

TECHNICAL QUALIFICATIONS

MAC/PC Applications and MS Office (Word, Excel, PowerPoint, and Visio)

 

Additional training includes: Computer Aided Inspections, Computer Systems Validation, FMEA Workshop, Auditing Medical Devices, Medical Device Process Validation, Quality Audits for Improved Performance, Industrial Sterilization for Drugs/ Devices, and Orientation to International Inspections.

 

PROFESSIONAL REFERENCES

 

1.             Myra Casey/Consumer Safety Officer (31+ years)

                Food and Drug Administration, Indianapolis R.P., 101 West Ohio St., Suite 500, Indianapolis, IN 46204-1994

                Tel: (317) 226-6500 FAX (317) 226-6506             

E-mail: myra.casey@fda.hhs.gov

 

2.             Maureen Garner/ President/ Consultant (11+ years)

                New World Regulatory Solutions, Inc., P.O. Box 5374, Tom’s River, NJ 08754                                                                                                           

              Tel: (732) 779-7422

              E-mail: nwrsinc@gmail.com

 

3.             Christine Smith/ Human Resources Manager (10+ years)

                Sultan Healthcare, 411 Hackensack Avenue, 9th Floor, Hackensack, NJ 07601

                Tel: (800) 637-8582

               

4.           Steven Baryschpolec/ Quality Consultant (9+ years)

              Steven Baryschpolec’s Cell: (908) 884-1936

 

5.             Ben Tsai/ President (6+ years)

                PAHI, 525 International Parkway, Suite 507, Richardson, Texas 75081

Tel: (972) 235-9331

 

6.             Victor Rodgers/ Consultant (8+ years)

                Victor Rodgers cell: 574-386-7732

                Victor Rodger’s e-mail: vicmr@aol.com

 

7.           Dennis Moore/ Principal Consultant/ Owner (6+ years)

              AUK Technical Services, LLC., 468 N. Camden Dr., Suite 269 C, Beverly Hills, CA 90210

              Dennis Moore's tel: 916-300-5319

              Dennis Moore's E-mail: dm@auk.com

 

8.           Christopher Rush/ Principal Consultant/Owner (4+ years)

              FDA Quality and Regulatory Consultants, Inc., PO Box 2590, Cedar Park, TX 78630

              Chris Rush's tel:  214 529-0248

              Chris Rush's E-mail: chris@cdrconsultng.net

 

9.             Dr. R. Donald Green/ Consultant (2+ year)

                R. Donald Green’s E-mail: drdg@prodigy.net

 

10.          Dr. Mai Evans (> 1 year)

                Dr. Mai Evans’ E-mail: propham@ptd.net