Principal Regulatory Affairs Specialist
$131,000–$142,000 year
On-siteEden Prairie, Minnesota, United States
Job Summary
Develop and execute regulatory plans for new product marketing submissions and changes to existing devices, including authoring 510(k) Premarket Notifications, EU MDR Technical Documentation, and Canadian Licensing Submissions. Coordinate cross-functional support for worldwide registrations and represent the company in interactions with US and international regulators during submission reviews, approvals, and audits. Review, edit, and approve project documentation while communicating global regulatory requirements to project teams and cross-functional partners. Identify emerging regulations and industry trends to recommend strategies ensuring compliance and support business objectives. Serve as the primary point of contact with external regulatory consultants and leverage digital and generative AI tools to improve submission efficiency and quality. Mentor junior regulatory staff and drive continuous improvement initiatives to enhance regulatory processes and operational efficiency.
Required Qualifications
- Minimum Bachelor's degree
- 7+ years of experience in medical device Regulatory Affairs
- Demonstrated experience with 510(k), EU CE Marking, and Health Canada submissions
- Understanding of FDA, EU MDD and MDR, Australia and Canada regulatory framework including how to comply with standards and regulations
- Experience successfully leading FDA meetings, such as pre-submissions and submission issue request meetings
- Effective written and verbal communication skills
- Technical writing and editing skills
- Ability to develop clear, concise, and timely oral and written reports
- Ability to communicate complex information and regulatory decisions tactfully and concisely to all levels of audiences with varying degrees of familiarity
- Ability to solve complex problems through the application of critical thinking skills
- Demonstrated proficiency using approved digital productivity and generative AI tools (e.g., Microsoft 365 Copilot or equivalent) to support document development, data analysis, research, communication, and process efficiency while maintaining appropriate human oversight and accountability for final work product
- Ability to work effectively in a matrixed environment and influence internal partners to achieve desired business outcomes
- Experience evaluating regulatory considerations associated with software-enabled, connected, cybersecurity-focused, artificial intelligence (AI), and machine learning-enabled medical devices
- High concentration and attention to detail to accurately assess compliance to applicable regulations for medical device manufacturers and comparing them to internal processes, policies, procedures and other quality-related documentation, which may involve point-by-point comparisons
- Detail oriented
- Deadline sensitive
- Frequent high-pressure situations
- Travel up to 1-2 times annually for 2-3 days duration each trip
Desired Qualifications
- RAC Certification
- Bachelor's degree in science, engineering or related technical discipline
- 10+ years or greater of experience in the medical device industry
- 10+ years or greater working in Regulatory Affairs
- Advanced level of FDA, Health Canada, TGA, and EU submission experience, including EU MDR
- International regulatory submission experience, including Japan and China
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