FDA 510(k) Regulatory Strategist

A healthcare technology company is seeking a Regulatory Affairs Specialist to manage and prepare FDA 510(k) submissions and documentation for international regulatory bodies. The ideal candidate will have a Bachelor's degree in a technical field and at least five years of experience in medical device regulation. Key responsibilities include acting as a liaison with regulatory authorities, reviewing documentation for compliance, and collaborating with cross-functional teams to ensure successful submissions. Sterilization experience is a plus. #J-18808-Ljbffr