Regulatory Affairs Manager

Regulatory Affairs Program Manager (Medical Device Divestiture) Location: Raynham, MA / West Chester, PA / Palm Beach Gardens, FL (Hybrid 3-4 days onsite) Duration: 12+ Months (Extension Possible) Overview We are seeking an experienced Regulatory Affairs Program Manager to lead a large-scale Medical Device Divestiture initiative. This role will manage the transfer of global regulatory registrations, submissions, and documentation from a large healthcare organization to a newly established medical device company while ensuring regulatory compliance and seamless execution. Key Responsibilities Lead regulatory activities supporting a global divestiture program. Complete and execute the Regulatory Registration Transfer Strategy. Manage ownership transfers, amendments, renewals, notifications, and new submissions. Coordinate with cross-functional Regulatory, Quality, and Project teams. Identify project risks, develop mitigation plans, and ensure GMP compliance. Maintain project documentation, timelines, and stakeholder communication. Required Skills 10+ years of Regulatory Affairs experience in the Medical Device industry. Hands‑on experience with Divestiture/Business Separation projects. Strong Regulatory Program Management experience. Expertise with FDA 510(k), PMA, global registrations, labeling changes, design changes, and regulatory submissions. Knowledge of registration ownership transfers, submission pathways, and health authority interactions. Excellent communication, leadership, and stakeholder management skills. #J-18808-Ljbffr