Regulatory Affairs Program Manager

Title:
Regulatory Affairs Program Manager (Medical Device Divestiture)

Position Overview

We are seeking an experienced Regulatory Affairs Program Manager to lead the regulatory workstream for a large-scale corporate divestiture involving the transition of regulatory documentation and registrations from a global pharmaceutical/biotechnology/medical device organization to a newly established global medical device company.

This is a highly visible program leadership role requiring deep expertise in medical device regulatory affairs, global registration strategies, and complex regulatory transfer projects. The ideal candidate will combine strong hands-on regulatory knowledge with proven program management experience to ensure a seamless regulatory transition while maintaining global compliance.

Key Responsibilities

• Lead the regulatory workstream for a global divestiture and regulatory separation initiative.
• Review, validate, and finalize the existing Regulatory Separation Plan (currently approximately 80% complete).
• Develop and execute the Regulatory Registration Transfer Strategy and Plan.
• Identify and manage all product registrations requiring ownership transfer, amendments, renewals, notifications, and new regulatory submissions.
• Coordinate regulatory activities across global cross-functional teams, including Regulatory Affairs, Quality, Legal, Operations, Supply Chain, and Commercial organizations.
• Ensure continued compliance with applicable global regulatory requirements and GMP standards throughout the transition.
• Assess regulatory risks, identify gaps, develop mitigation strategies, and implement contingency plans.
• Serve as the primary regulatory program lead for project planning, execution, governance, and stakeholder communication.
• Track project milestones, maintain documentation, and provide regular status updates using project management tools.
• Support interactions with global regulatory authorities as needed throughout the transition process.

Required Qualifications

• Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or a related discipline.
• 10+ years of Regulatory Affairs experience within the Medical Device industry.
• Proven experience managing Regulatory Affairs activities during a divestiture, acquisition, or business separation project.
• Extensive experience leading large, global cross-functional Regulatory Affairs programs.
• Strong project and program management experience with multiple concurrent regulatory initiatives.