Logo
job logo

SaMD Regulatory Lead - FDA Submissions & QMS Expert

Katalyst CRO, Jacksonville, FL, United States


A leading medical technology firm based in Florida is seeking a Regulatory Affairs Manager to oversee U.S. regulatory activities for its medical devices. Responsibilities include leading regulatory submissions, ensuring compliance with quality management systems, and collaborating with cross-functional teams. The ideal candidate will have a Bachelor's degree in a relevant field and over 5 years of experience in regulatory affairs, particularly for software-based medical devices. Relocation to Boston may be required. #J-18808-Ljbffr