Regulatory Affairs Program Manager

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.
• Cook up coordination 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.

Pay

Commensurate with experience.

Schedule

Hybrid 3-4 days onsite.

Benefits

N/A