The Regulatory Affairs Program Manager will be the Project Manager leading the Divestiture / transferring of all Regulatory documents from the large global pharmaceutical / biotech / medical device organization to a new, global exclusively Medical Device organization.

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:

• At least 10+ years of Regulatory Affairs experience within Medical Device Industry. Proficient with all:
  • FDA 510(k)
  • PMA products
  • Design changes
  • Labeling changes
  • Global registrations
  • Regulatory submission
• Large Program Management Experience leading global Regulatory programs including managing cross-functional RA Programs
• Must understand:
  • Registration ownership transfers
  • Notification requirements
  • Submission pathways
  • Health authority interactions

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.