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A medical technology company in Bedford is looking for a Regulatory Affairs Manager II to lead their post-market regulatory program. This role involves managing a team of regulatory professionals to ensure compliance with worldwide regulations for medical devices. Key responsibilities include overseeing vigilance reporting, coordinating product recalls, and maintaining a robust Post-Market Surveillance program. Candidates should have a strong background in regulatory affairs, excellent leadership skills, and significant experience in the medical device industry, with a focus on FDA and Health Canada regulations.
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