Regulatory Affairs Program Manager - Medical

Regulatory Affairs Program Manager

Duration: 12 Months Contract

We are seeking an experienced Regulatory Affairs Program Manager to lead the regulatory workstream for a large-scale Medical Device divestiture project. This role will be responsible for managing the transfer of regulatory documentation, registrations, and regulatory ownership from a global healthcare organization to a new global medical device organization.

The ideal candidate will have extensive Medical Device Regulatory Affairs experience, a strong background in Regulatory Program Management, and prior experience supporting divestitures, acquisitions, or business separation projects.

• Lead the Regulatory Affairs workstream for a global divestiture and regulatory separation project.
• Review, validate, and finalize the Regulatory Separation Plan.
• Develop and execute the Regulatory Registration Transfer Strategy and Plan.
• Identify and manage all regulatory registrations, ownership transfers, amendments, renewals, notifications, and new submissions.
• Ensure regulatory compliance throughout the transition while maintaining GMP requirements.
• Identify project risks, develop mitigation strategies, and manage contingency plans.
• Coordinate cross-functional teams including Regulatory Affairs, Quality, Legal, Supply Chain, Manufacturing, and Project Management.
• Track project milestones, deliverables, and documentation using project management tools.
• Communicate project status, risks, and updates to leadership and key stakeholders.
• Support interactions with global regulatory authorities as needed.

• Bachelor's degree in a relevant Life Sciences, Engineering, or related discipline.
• 10+ years of Regulatory Affairs experience within the Medical Device industry.
• Proven experience managing Regulatory Affairs programs and large cross-functional projects.
• Prior experience supporting divestiture, acquisition, or regulatory separation projects.
• Strong knowledge of: FDA 510(k), PMA products, Global regulatory registrations, Regulatory submissions, Design changes
  
  Labeling changes
• Thorough understanding of:
  Registration ownership transfers, Regulatory notification requirements, Submission pathways, Health authority interactions
• Strong knowledge of GMP and regulatory compliance requirements.
• Excellent leadership, communication, stakeholder management, and organizational skills.

• Experience leading global Regulatory Affairs initiatives for medical device organizations.
• Experience managing complex, multi-site regulatory projects in a matrixed environment.
• PMP or equivalent project management certification is a plus.