Project Manager (Contract)

Bluestarpartners; Plymouth (MN); Hybrid; USD 60,000 - 80,000; Full time

Job summary

A leading company in the medical device sector seeks a Project Manager to lead documentation and remediation projects. Candidates should possess a bachelor's degree, with a minimum of 7 years in project management, especially in regulated environments. This hybrid role requires strong leadership to influence teams and ensure compliance with regulatory standards.

Qualifications

• Minimum 7+ years of project management experience.
• Experience leading projects in regulated industries (Medical Device/Pharma preferred).
• Familiarity working within Regulatory Affairs.

Responsibilities

• Lead the planning and execution of remediation projects involving 15–20 team members.
• Develop and manage project plans, coordinate responsibilities, and drive toward goals.
• Report directly to leadership on risks, milestones, and deliverables.

Skills

Project Management in a Regulated Environment

Cross-Functional Team Leadership

Documentation and Compliance Coordination

High Organizational and Communication Skills

Non-IT Project Execution

Education

Bachelor's degree

Tools

MS Project

MS Office Suite

SharePoint

Job description

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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)

:

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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Project Management and Information Technology

• Industries

  Hospitals and Health Care, Non-profit Organizations, and Government Administration

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