Regulatory Affairs Manager

Job Title

Responsibilities : Develop and execute U.S. regulatory strategies to support product submissions (e.g., IDE, 510(k), De Novo) and post-market requirements. Serve as the primary point of contact with the U.S. Food and Drug Administration (FDA) and their regulatory agencies, leading meetings, Q-Subs, and communications. Collaborate with cross-functional teams (R&D, Clinical, ...)