What are the responsibilities and job description for the Regulatory Affairs (Program Manager) position at United Consulting Hub?
Role :: Regulatory Affairs (Program Manager)
Locations :: Multiple Locations
Employment Type :: W2 Contract
We are seeking an experienced Regulatory Affairs Program Manager with a strong Medical Device background to lead a global Regulatory Divestiture Program.
MUST HAVE:
- Must have significant hands-on Regulatory experience within Medical Device Industry
- Must have experience doing Regulatory Affairs on a Divestiture Project
- Must have RA Program Management experience
Responsibilities:
- The Regulatory Separation Plan is 80% complete. This Regulatory Program Manager will confirm the Regulatory Separation Plan and their first main deliverable will be to complete the Regulatory Registration Transfer Strategy / Plan.
- This would include identifying all registrations; coordinating all ownership transfers, amendments, renewals, notifications, and any new submissions.
- Ensure consistent Regulatory Compliance; GMP
- Risk Management – identify gaps and potential risks; create contingency plans
- Continuously document project details and update accordingly within Project Management tracking system
Key Skills & Experience:
10 years in Medical Device Regulatory Affairs
Regulatory Divestiture or Separation Projects
Regulatory Program Management
FDA 510(k) and PMA Submissions
Global Regulatory Registrations and Submission Strategy
Registration Ownership Transfers
GMP Compliance and Risk Management
Cross Functional Leadership