Jennifer Moyer

Consultant, Medical Devices at Biologics Consulting
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Contact Information
us****@****om
(386) 825-5501
Location
US
Languages
  • English -

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Credentials

  • Six Sigma Yellow Belt
    Coursera
    Nov, 2020
    - Nov, 2024
  • Standards Professional Certification (CStd)
    Society for Standards Professionals
    Jan, 2018
    - Nov, 2024
  • Master of Science
    Northeastern University

Experience

  • Biologics Consulting
    • United States
    • Biotechnology
    • 1 - 100 Employee
    • Consultant, Medical Devices
      • Jan 2021 - Present

      • Works directly with medical device companies to advise them on regulatory strategy • Supports clients in compiling, preparing, and reviewing regulatory submission, include 510(k)s, special 510(k)s, De Novos, and presubmissions. • Expertise in preparing, organizing, and submitting documentation for FDA submissions, including Refuse to Accept (RTA) and eCopy requirements. • Works directly with medical device companies to advise them on regulatory strategy • Supports clients in compiling, preparing, and reviewing regulatory submission, include 510(k)s, special 510(k)s, De Novos, and presubmissions. • Expertise in preparing, organizing, and submitting documentation for FDA submissions, including Refuse to Accept (RTA) and eCopy requirements.

  • AAMI
    • United States
    • Non-profit Organization Management
    • 1 - 100 Employee
    • Senior Director, Standards
      • Mar 2020 - Jan 2021

      • Direct oversight of and team lead for the AAMI portfolio of 505 vertical medical device standards.• Responsible for ensuring efficient and high-quality project management within my team.• Supervise and mentor two Director level staff.• Direct oversight of 32 national medical device and medical systems committees and working groups, as well as 6 international ISO medical device groups under ISO/TC 150/SC 6, Active implants, and 30 international IEC groups under IEC/SC 62D, Electromedical equipment.• Responsible for project management and maintenance of 39 active projects and 114 published projects across national and international groups and navigating the consensus process with clinical, regulatory, and industry stakeholder groups.• U.S. Technical Advisory Group (TAG) Administrator to ISO/TC 150/SC 6 and Technical Officer for U.S. TAG to IEC/SC 62D.• Responsible for maintaining the AAMI Standards Program Policies and Procedures.• Serve as internal AAMI resource on international regulatory environment.Other highlights include: • Manage AAMI Standards Board, the policy committee responsible for maintaining the Standards Program Policies and Procedures and approving all new work and final publications in the entire AAMI standards program (170 published documents and 130 new or revised in development). • Initiate improvement of existing training materials for remote training of co-chairs of all AAMI committees and new standards committee participants.• Identify department process gaps and develop solutions to improve internal workflow.

    • Senior Director, Quality Assurance and Standards
      • Sep 2018 - Mar 2020

      • Direct oversight of the entire AAMI standards portfolio. Responsible for identifying and implementing process improvements that support efficient and high quality project management across the standards department.• Supervise and mentor two Director level staff.• Direct oversight of 16 national medical device and medical systems committees and working groups, as well an international ISO medical device sub-committee with 7 active working group, ISO/TC 150/SC 6, Active implants.• Responsible for 46 projects in active development across national and international groups and navigating the sometimes delicate consensus process with clinical, regulatory, and industry stakeholder groups.Other highlights include: • Manage AAMI Standards Board, the policy committee responsible for maintaining the Standards Program Policies and Procedures and approving all new work and final publications in the entire AAMI standards program (170 published documents and 130 new or revised in development). • Initiate improvement of existing training materials for remote training of co-chairs of all AAMI committees and new standards committee participants.• Identify department process gaps and develop solutions to improve internal workflow.

    • Director, Standards
      • Apr 2008 - Aug 2018

      • Direct oversight of 20 national medical device and medical systems committees and working groups, and an international ISO medical device sub-committee, ISO/TC 150/SC 6, Active implants. Responsible for 46 projects in active development across national and international groups and navigating the sometimes delicate consensus process with clinical, regulatory, and industry stakeholder groups.• US TAG Administrator to ISO/TC 150/SC 6 and its six working groups. Also responsible for coordinating the US input and position to select IEC/SC62A and IEC/SC62D joint working groups.Other highlights include:• Staff lead for 2016 ANSI audit and 2018 special audit of the standards program. Reaccreditation was successfully achieved in June 2018.• Manage AAMI Standards Board, the policy committee responsible for maintaining the Standards Program Policies and Procedures and approving all new work and final publications in the entire AAMI standards program (170 published documents and 130 new or revised in development). • Serve as department liaison to the AAMI Foundation patient safety initiatives in the areas of medical device alarms, infusion pumps, and home care. Leverage the Foundation outputs into new standards initiatives in the relevant committees. • Represent AAMI on the ANSI Conformity Assessment Policy Committee (CAPC) and the International Conformance Assessment Committee (ICAC).• Serve as an internal resource on the international regulatory environment, in particular with the evolving European Medical Device Regulations and the upcoming impact on industry members, as well as the future of consensus standards in the regulatory clearance process.• Maintain training materials and provide in-person and remote training to co-chairs of all AAMI committees.

  • Association of Home Appliance Manufacturers
    • Washington D.C. Metro Area
    • Manager, Performance Standards
      • Mar 2006 - Apr 2008

      • Oversight of AHAM’s entire technical performance standards portfolio of 25 documents. Responsible for managing and facilitating 14 member committees in the development of national standards in both the major appliance and portable appliance divisions. Also responsible for managing ANSI’s American National Standard (ANS) public review process and ensuring compliance with ANSI procedures for the organization. • US TAG Administrator to IEC/TC 59, Performance of household and similar electrical appliances, and subcommittees A (electric dishwashers), D (electrical laundry appliances), F (surface cleaning appliances), K (electrical cooking appliances) – Responsible for coordinating the US input and position to IEC/TC 59 and subcommittees and serving as US representative to IEC/TC 59. Serve on ANSI’s US National Committee (USNC) Technical Management Committee (TMC) representing AHAM. • Participate in 11 Underwriters Laboratories (UL) STPs – Responsible for coordinating AHAM member input into the UL safety national standards development in order to ensure that industry positions were represented.

  • API - American Petroleum Institute
    • United States
    • Oil and Gas
    • 400 - 500 Employee
    • International Standards Program Assistant
      • Nov 1996 - Mar 2006

      • Assistant Secretary to ISO/TC 67, Materials, equipment and offshore structures for petroleum, petrochemical and natural gas industries. Responsible for tracking progress of over 100 international technical standards across the technical committee and 6 sub-committees and successfully managing the ISO process at the Technical Committee level. • Secretary to ISO/TC 67/SC 4, Drilling and production equipment. Directly responsible for managing the subcommittee technical program of over 25 document, including document editing for 5 working groups. • Assistant Secretary to ISO/TC 28, Petroleum products and lubricants. Responsible for tracking progress of over 90 active technical standards within the technical committee and assisting with managing the ISO process at the Technical Committee level. • US TAG Administrator to ISO/TC 193, Natural gas. Responsible for coordinating the US input and position to ISO/TC 193. • Assistant US TAG Administrator to ISO/TC 28, Petroleum products and lubricants. Responsible for helping coordinate the US input to ISO/TC 28.

Education

  • Northeastern University
    Master of Science - MS, Regulatory Affairs for Drugs, Biologics, and Medical Devices (concentration on international RA)
    2017 - 2020
  • Webster University
    Master's degree, Management & Leadership
    2012 - 2014
  • Drew University
    BA, English lit
    1986 - 1990

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