Regulatory Affairs Project Manager

DEKA Research & Development • Manchester, NH

7d

About The Position

DEKA Research & Development has an immediate opening for a Regulatory Affairs Project Manager to contribute to a dynamic, medical device research and development environment. The individual in this high visibility role will have a significant and direct impact on the success of the innovative life science devices that DEKA develops. The person in this role will formulate and execute regulatory strategies to deliver FDA approval or clearance as well as international approvals including CE Marking.

Requirements

• BS in a technically related field
• Minimum of 5 years direct work experience in a medical device, drug or biologic regulatory role with demonstrated success in obtaining product approvals/clearances
• Experience in direct FDA interactions including premarket notifications, IDE’s, Q-submissions and participation in face-to-face meetings
• Strong written and verbal communication skills
• Demonstrated ability to continually balance priorities in a dynamic and fast-paced environment
• Expertise in current FDA processes including the eSTAR submission tool, establishment registration and listing, UDI, product labeling, and post-market reporting including MDR’s and Field Action Reporting
• Experience in Medical Device Quality Regulations including Quality Management Systems Regulations (QMSRs), ISO 13485, and MDSAP

Nice To Haves

• Demonstrated ability in expanding regulatory organization capabilities
• Experience with drug, biologic and combination product approvals a plus
• RAC certification a plus

Responsibilities

• Work in close association with customers and development teams to define and execute regulatory approval and clearance programs, including establishing regulatory requirements and leading the preparation and submission of 510(k)s, PMAs, IDEs, Technical Files, and other international dossiers
• Provide leadership and guidance to R&D in developing successful regulatory strategies across the entire product life cycle
• Mentor regulatory affairs staff, as well as internal cross-functional partners, on effective regulatory strategies and tactics
• Lead FDA interactions including in-person meetings, teleconferences, written submissions and other Agency engagements as needed
• Participate in the design and conduct of clinical trials, and assist in obtaining and maintaining the appropriate regulatory approvals from the FDA, IRBs and/or Ethics Boards
• Continually improve internal regulatory processes and procedures to increase efficiency and reduce time to market while maintaining the highest levels of compliance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level