Principal Regulatory Specialist
ID18028
Job TypeDirect Hire
Remote TypeHybrid
Our mid-sized medical device client is adding a Principal Regulatory Affairs Specialist to the team! This Principal RA Specialist is an expert-level team member responsible for leading regulatory activities to support global product approvals and lifecycle management for the company's products. This role involves hands-on development of regulatory strategies, preparation of submissions, and direct interaction with regulatory bodies. The specialist ensures compliance with global regulations and corporate standards, maintains product approvals, and manages re-registration processes.
Your role with the company:
- 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.
Desired profile:
- Bachelor’s degree in Science, Engineering, or a related discipline
- 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 such as combination devices (drug/device)
- 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.
- This role is onsite 2-3 days a week in the Plymouth, MN office.