Manchester, United States
12 months ago
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