Principal Regulatory Affairs Specialist
$120,000–$135,000 year
Hybrid · Eden Prairie, Minnesota, United States
Job Summary
Principal Regulatory Affairs Specialist applies advanced knowledge of U.S. FDA medical device regulations (21 CFR Parts 807, 801, 820/QMSR, 830), ISO 13485, ISO 14971 to execute regulatory strategies, submissions, and lifecycle compliance for Class I and II medical devices. This individual contributor role focuses on hands-on FDA regulatory execution, including preparing/supporting FDA 510(k)s, pre-submissions/Q-submissions, letters to file, regulatory assessments, FDA question responses, and related documentation. Working knowledge of EU MDR and other international frameworks is preferred but core emphasis is U.S. regulatory execution, 510(k) submission support, and ongoing FDA compliance. Independently assesses regulatory impact of product/design/manufacturing/ labeling/software/supplier/process changes; prepares technical documentation and regulatory submissions; supports implementation of regulatory pathways; provides regulatory analysis for product development, commercialization, change control, and post-market activities; collaborates with cross-functional teams; and maintains compliance across the product lifecycle.
Required Qualifications
- Bachelor's degree in a scientific discipline (biochemistry, biology, chemistry) or engineering discipline (mechanical, biomedical, chemical, electrical, software, etc.)
- Minimum of 7 years of direct medical device Regulatory Affairs experience; or minimum of 5 years of direct medical device Regulatory Affairs experience with an advanced degree in a related discipline
- Direct, hands-on experience preparing and supporting FDA 510(k)s for medical devices, including substantial equivalence documentation, submission compilation, FDA question responses, and clearance support
- Experience supporting direct FDA interactions (pre-submissions/Q-submissions, interactive review, deficiency responses, meeting preparation, regulatory correspondence)
- Preferred: Master’s degree in Regulatory Affairs or related field; Regulatory Affairs Certification (RAC) is a plus
- Strong knowledge of FDA medical device requirements including establishment registration, device listing, GUDID/UDI, labeling, quality system, and post-market obligations
- Ability to execute regulatory strategies, assess submission requirements, evaluate predicate documentation, and prepare compliant implementation plans
- Ability to conduct formal regulatory impact analyses for design, manufacturing, labeling, software, process, supplier, and site changes
- Ability to write clear, accurate regulatory submissions, summaries, response letters, and internal decision documentation
- Experience interpreting FDA guidance documents and standards (ISO 14971, IEC 62304, IEC 60601) and familiarity with EU MDR is preferred
- Strong cross-functional collaboration skills with R&D, Quality, Manufacturing, Clinical, Marketing, and Operations
- Project execution skills to manage submission tasks and timelines in a fast-paced environment
- Ethical judgment and integrity in all regulatory activities
- Willingness to travel domestically up to 5%
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