Hybrid Senior Regulatory Affairs Leader - FDA Submissions

A clinical stage startup in Irvine, CA is seeking a Principal Regulatory Affairs Specialist to lead the execution of key U.S. FDA submissions for Class III cardiovascular medical devices. The role involves developing regulatory strategies, partnering with cross-functional teams, and guiding submissions with minimal oversight. Candidates should have extensive regulatory experience and strong communication skills to thrive in a dynamic environment. #J-18808-Ljbffr