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Job

Regulatory Affairs Project Manager

  • Job ref:

    11495

  • Location:

    Manchester, United States

  • Sector:

    Quality Engineers

  • Contact:

    Bob Giusti

  • Published:

    5 months ago

  • Consultant:

    Bob Giusti

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.

Responsibilities:

  • 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

Qualifications:

  • 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