Project Manager II

Plymouth, MN

Pay Range: $66–$71/hr
Duration: 6 months, with possibility of extension based on performance and budget.
Location: Onsite – Plymouth, MN (Local candidates preferred)
 
Position: Project Manager – Regulatory Affairs
We are currently seeking an experienced Regulatory Affairs Project Manager to support product remediation activities in a medical device environment. This role will require someone with a proven ability to lead cross-functional teams without direct authority and drive documentation deliverables through completion.
 
Key Responsibilities:
  • Lead remediation projects in a Regulatory Affairs setting
  • Drive timelines and accountability across a core team of 15–20 people
  • Schedule and run weekly team meetings to track progress
  • Manage the creation and submission of remediation documentation
  • Ensure all deliverables meet quality expectations and project deadlines
  • Influence and hold stakeholders accountable despite no formal reporting structure
 
Ideal Candidate Will Have:
  • 5+ years of experience in Regulatory Affairs project management or similar roles
  • Prior experience with MDR (Medical Device Regulation) is a strong plus
  • Background in medical devices highly preferred (other regulated industries considered)
  • Strong technical understanding and experience working with documentation
  • Clear examples of leadership, influence, and ownership in cross-functional environments
 
Note: This is an onsite position. Only candidates currently local or willing to relocate at their own expense will be considered.


 

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