Regulatory Affairs Project Manager

  • Job ref:


  • Location:

    Manchester, United States

  • Sector:

    Quality Engineers

  • Contact:

    Bob Giusti

  • Published:

    12 months ago

  • Consultant:


Regulatory Affairs Project Manager


Regulatory Affairs Project Manager needed to contribute to a dynamic medical device research and development environment. Will formulate and execute regulatory strategies to deliver FDA approval or clearance as well as obtain the CE Mark and other international approvals.


  • Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process
  • Define and execute regulatory approval programs, with focus on the preparation and submission of 510(k)s, PMAs, IDEs, Technical Files, etc.
  • Participate in the design and conduct of clinical trials, including leading efforts to obtain and maintain the appropriate regulatory approvals from the FDA, IRBs and/or Ethics Boards
  • Lead FDA interactions including in-person meetings, teleconferences, and other Agency communications as needed


  • BS in a technically related field
  • Minimum of 5+ years direct work experience in a medical device regulatory role with demonstrated success in obtaining product approvals/clearances
  • 510K experience
  • Experience in medical device regulations including U.S. FDA Quality Systems Regulations (QSRs), ISO 13485, product registrations, UDI, product labeling, and EU MDR requirements.
  • Experience in direct FDA interactions including premarket notifications, IDE’s, Q-submissions and in-person meetings preferred