Regulatory Affairs Program 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)

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.

• 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.

• 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.