Regulatory Affairs Program Manager - Medical Device Manufacturing

Responsibilities

• Confirm the Regulatory Separation Plan and complete the Regulatory Registration Transfer Strategy / Plan.
• Identify all registrations, coordinate ownership transfers, amendments, renewals, notifications, and new submissions.
• Ensure consistent Regulatory Compliance, adhering to GMP standards.
• Risk Management: Identify gaps and potential risks, create contingency plans.
• Document project details continuously and update the Project Management tracking system accordingly.

Key Skills & Experience

• At least 10+ years of Regulatory Affairs experience within Medical Device Industry, proficient with:
• FDA 510(k)
• PMA products
• Design changes
• Labeling changes
• Global registrations
• Regulatory submissions
• Large Program Management Experience leading global Regulatory programs, including managing cross-functional RA Programs.
• Understanding of registration ownership transfers, notification requirements, submission pathways, and health authority interactions.

Requirements

MUST HAVE:

• Significant hands-on Regulatory experience within Medical Device Industry
• Experience doing Regulatory Affairs on a Divestiture Project
• RA Program Management experience