Regulatory Affairs Program Manager

Job SummaryThe Regulatory Affairs Program Manager will serve as the lead Project Manager for a global Regulatory Affairs divestiture program, responsible for the successful separation and transfer of regulatory documents, registrations, and compliance activities from a large global pharmaceutical/biotechnology/medical device organization to a newly established global medical device-focused organization.This role requires deep hands-on Regulatory Affairs expertise within the Medical Device industry, combined with strong global program management experience. The ideal candidate will lead cross-functional regulatory separation activities, ensure regulatory continuity, manage risks, and execute regulatory transfer strategies across global markets.Key Responsibilities:Lead and manage the Regulatory Affairs workstream for a global divestiture/separation program.Review, validate, and finalize the Regulatory Separation Plan, ensuring alignment with business objectives and regulatory requirements.Develop and execute the Regulatory Registration Transfer Strategy and Plan, including:Identification and assessment of all regulatory registrations worldwide.Coordination of registration ownership transfers.Management of regulatory amendments, renewals, notifications, and new submissions.Alignment with global health authority requirements and timelines.Ensure ongoing regulatory compliance and continuity throughout the divestiture process, including adherence to applicable GMP requirements.Partner with global Regulatory Affairs teams, Quality, Clinical, Engineering, Operations, Supply Chain, Legal, and other cross-functional stakeholders.Identify regulatory gaps, compliance risks, and project dependencies; develop mitigation strategies and contingency plans.Manage project documentation, timelines, milestones, risks, issues, and action items within project management tracking systems.Provide regular program status updates to leadership and key stakeholders.Support regulatory interactions with global health authorities as required.Ensure successful transition of regulatory documentation and ownership responsibilities to the new medical device organization.Required Qualifications & ExperienceBachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, Pharmacy, or related discipline.10+ years of progressive Regulatory Affairs experience within the Medical Device industry.Proven experience leading Regulatory Affairs activities for a divestiture, separation, acquisition, or business transfer project.Strong Regulatory Affairs Program Management experience managing complex, global regulatory programs.Extensive knowledge of medical device regulatory pathways and global registration requirements.Hands-on experience with:FDA 510(k) submissionsPMA productsDesign changes and regulatory impact assessmentsLabeling changesGlobal regulatory registrationsRegulatory submissions and lifecycle managementDemonstrated understanding of:Registration ownership transfersRegulatory notification requirementsSubmission strategies and pathwaysHealth authority interactionsRegulatory compliance expectations