
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.
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