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.