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Job DescriptionJob Description
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 )
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
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
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 )
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
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