Job Title: Project Manager – Regulatory / Medical Device

Location: Plymouth, MN (Hybrid – Local Candidates Only)

Rate: $70 – $75/hr (W2 only)

Contract Duration: 6 Months (with possible extensions)

Contract Type: W2 (Must be authorized to work in the U.S.; no C2C, no visa sponsorships)

Overview:

We are seeking a Project Manager to lead remediation and documentation initiatives within the Regulatory Affairs space for a global medical device organization. While MDR experience is not required, the ideal candidate will bring strong project leadership, regulatory awareness, and organizational excellence. This is not an IT project management role — instead, it requires someone with the ability to lead cross-functional teams, influence without authority, and deliver complex documentation projects in a highly regulated environment.

Work Schedule:

• Candidates must be local to the Twin Cities area

• Must be able to attend onboarding/training onsite

• After initial onboarding, position is primarily remote, with occasional in-office meetings

Key Responsibilities:

• Lead the planning and execution of remediation projects involving 15–20 team members delivering regulatory documentation

• Develop and manage project plans, coordinate team responsibilities, and drive toward timeline and quality goals

• Schedule and lead weekly core team meetings, maintain action items, and ensure team accountability

• Partner with cross-functional stakeholders (Regulatory, Engineering, QA) to track and communicate project status

• Report directly to leadership and Director-level stakeholders on risks, milestones, and deliverables

• Navigate non-software, non-Agile environments with adaptability and structure

• Drive completion of product development documentation in preparation for regulatory submissions or product launch

Required Qualifications:

• Bachelor’s degree required

• Minimum 7+ years of project management experience, with proven success leading projects in regulated industries (Medical Device or Pharma preferred)

• Strong leadership and influence without authority experience

• Familiarity working within Regulatory Affairs or similar compliance-focused functions

• High proficiency in MS Project, MS Office Suite, and SharePoint

• Exceptional communication and organizational skills

• Demonstrated ability to manage multiple priorities and timelines effectively

Preferred Qualifications:

• Experience in medical device development or pharma

• Project management certifications (PMP, etc.) a plus

• Familiarity with MDR or other global regulatory frameworks is helpful, but not required

• Experience with remediation work in quality, regulatory, or technical documentation

Top Skills:

• Project Management in a Regulated Environment

• Cross-Functional Team Leadership

• Documentation and Compliance Coordination

• High Organizational and Communication Skills

• Non-IT Project Execution