Laborie · 1 day ago
Principal Regulatory Affairs Specialist
Plymouth, MN
Full-time
Hybrid
Lead/Staff
16+ years expLaborie is a world-class specialist medical company focused on advancing technologies that preserve and restore human dignity. The Principal Regulatory Affairs Specialist is responsible for leading regulatory activities for global product approvals and lifecycle management, ensuring compliance with global regulations and corporate standards.
Health CareManufacturingMedical
Responsibilities
Prepare and manage documentation for global regulatory submissions, registrations, and renewals
Define worldwide regulatory requirements for assigned products
Develop and execute submission strategies to support product approvals and lifecycle management
Collaborate cross-functionally to ensure regulatory compliance throughout product development and commercialization
Participate in external audits and ensure regulatory documentation is maintained and audit-ready
Support projects involving novel technologies with complex or undefined regulatory pathways
Serve as a core team member for new-to-market technologies (e.g., mobile medical apps, remote monitoring programs)
Develop regulatory strategies for complex technologies and cross-linked programs
Lead preparation and management of complex submissions (e.g., original PMA, Panel Track 180-day, Traditional 510(k))
Lead regulatory task forces for special projects (e.g., EU UDI, cybersecurity, process improvement initiatives)
Represent the company in regulatory trade and advocacy groups
Mentor and guide junior regulatory team members on regulatory projects and topics
Maintain up-to-date knowledge of global regulatory requirements
Perform additional responsibilities as assigned by management
Qualification
Required
Bachelor's degree in Science, Engineering, or a related discipline with 16+ years of regulatory affairs experience in the medical device industry (10+ years with a Master's degree)
Proven experience with U.S. Class III PMA submissions, Investigational Device Exemption (IDE) submissions, FDA pre-submissions, and EU MDR technical documentation
Experience with complex medical devices and/or combination devices
Strong understanding of quality system regulations and global regulatory guidelines
Excellent communication skills across all organizational levels
High level of organizational and planning capability
Solid working knowledge of medical devices, procedures, and terminology
Benefits
Paid time off and paid volunteer time
Medical, Dental, Vision and Flexible Spending Account
Health Savings Account with Company Funded Contributions
401k Retirement Plan with Company Match
Parental Leave and Adoption Services
Health and Wellness Programs and Events
Company
Laborie
Laborie is a world-class specialist medical company that makes and advances technologies that preserve and restore human dignity.
1001-5000 employees
H1B Sponsorship
Laborie has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (6)
2023 (3)
2022 (3)
2021 (2)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Audax Private Equity
2016-08-19Acquired
2012-07-19Private Equity
Leadership Team
Bo Jesper Hansen
Non Executive Director
Ray Laborie
Consultant for distributors of medical devices
Recent News
Precedence Research
2025-11-21
2025-11-15
2025-11-08
Company data provided by crunchbase