Global Post-Market Regulatory Lead (Medical Devices)
Werfen
Werfen is seeking a Regulatory Affairs Manager II in Bedford, Massachusetts, to lead its post-market regulatory program for IL-labeled medical devices. This role focuses on ensuring compliance with global regulations and managing a team dedicated to regulatory affairs. The ideal candidate will have a strong background in medical device regulation, a minimum of 5 years in management, and experience with FDA and Health Canada guidelines. The position offers competitive compensation, including a 10% annual bonus and various employee benefits. #J-18808-Ljbffr Werfen
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...the VP of R&D and lead the development of... ...including R&D, quality, regulatory, clinical and... ...History File and Device Master Record.... ...support to ongoing global clinical trials.... ...manufacturing of medical devices. Foster... ...reference the job posting in your email title...RegulatoryMedical deviceFull timeContract workWork at office- ...ECI ECI’s mission is to be the global leader of professional consulting... ...with 10+ years' experience to lead validation strategy and execution for medical device products, manufacturing processes... ..., ISO 13485, EU MDR, and global regulatory requirements. The ideal candidate...RegulatoryMedical deviceFor contractorsVisa sponsorshipWork visaFlexible hours
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