POSITION SUMMARY

The Product Regulatory Compliance Manager is responsible for all product design compliance related issues and works directly with Laboratory personnel to ensure quality systems meet ISO 13485:2016 and QSR 21 CFR Part 820 compliance. Additionally, this person is responsible for ensuring all relevant product design control, requirements management and risk management procedures are implemented and effective. This role will work closely with cross functional team members to ensure that product requirements are managed and traced per quality procedures and/or protocols such that subsequent FDA and RoW Regulatory submissions are approved.

The Product Regulatory Compliance Manager establishes and maintains routine design control meetings to include design reviews which ensure product specifications are managed throughout product life cycles. This role ensures product specifications/requirements must be managed with regards to Risk Management principles of ISO 14971:2012, Risk Management for Medical Devices. The Product Regulatory Compliance Manager will utilize available software tools/applications to automate requirements management and risk management. This role will facilitate interfacing with strategic partners to manage product specifications/requirements in real-time.

PRIMARY DUTIES

  1. Develops and maintains quality systems utilizing existing laboratory policies and procedures.
  2. Develops and maintains design control procedures for product requirements management.
  3. Develops protocols, statistical analysis plans and verification and validation studies.
  4. Compiles production of final reports for FDA and RoW Regulatory submissions.
  5. Supports and maintains product risk mitigation and risk management methodology.
  6. Conducts product design reviews with cross-functional teams and maintains records.
  7. Maintains and monitors compliance with regulatory agency guidelines such as New York State Department of Health (NYS DOH), College of American Pathologists (CAP), Centers for Medicare & Medicaid (CMS, CLIA), and FDA 21 CFR Part 820 / ISO 13485:2016. Participates in on-site regulatory reviews as necessary.
  8. Prepares and reviews standard operating procedures. Supports the controlled electronic document repository, MediaLab, JAMA Connect and SOPs and Policies.
  9. Prepares other written documentation as required by the profession and the department; maintains, distributes, analyzes and projects information for required records, reports and statistics as directed.
  10. Attends various meetings as required.
  11. Performs other related duties as assigned or requested.

OTHER DESCRIPTIVE ELEMENTS

The Product Regulatory Compliance Manager reports to the Executive Director, Regulatory Affairs and Quality Assurance. The incumbent must have the education, experience and authority to discharge the responsibilities of the position and must have access to personnel at all levels of the organization as required.

RELATIONSHIP WITH OTHERS

The Product Regulatory Compliance Manager has routine contact with all departments/personnel.

FUNCTIONAL RESPONSIBILITIES

  1. Must be familiar with a personal computer and pertinent Laboratory quality system(s).
  2. Must demonstrate the ability to work as cross functional team leader.
  3. Must demonstrate the ability to solve problems and interpret Regulatory requirements.

MACHINES, TOOLS AND EQUIPMENT USED

  1. Personal computer: MS Word™, MS Excel™, MS PowerPoint™
  2. Product Design Software Applications i.e. JAMA Connect™
  3. Document Management Applications
  4. Various office equipment