Give product teams a clear route from software development to regulatory submission, identifying evidence gaps before they hold up a release.
Build U.S. and international submission packages for new products and changes to approved devices.
Evaluate software, firmware, and hardware updates to determine filing requirements and supporting documentation.
Connect software testing, risk management, and cybersecurity evidence into a defensible submission.
Resolve agency questions by gathering technical input and writing responses that directly address the issue.
Keep approved products compliant as functionality, documentation, and regulatory expectations change.
Help engineering and quality teams turn regulatory requirements into development decisions and release plans.
What we're looking for...
Direct regulatory affairs experience with Class II and Class III medical devices, including preparation of FDA submissions.
Experience covering standalone medical software, embedded software, and products integrating software with mechanical and electronic components.
Ability to assess software lifecycle records, verification and validation results, cybersecurity documentation, and product risks.
A bachelor's degree in engineering, life sciences, or a related field; familiarity with manufacturing and quality requirements; and the ability to manage submissions independently.
U.S. residence in the Eastern Time Zone and availability for occasional travel. Nice to have: Regulatory Affairs Certification.
Compensation: $125-140K base + 10% bonus.
Benefit Highlights: Day-one health/dental/vision, 401(k) w/ match after 90 days, 20 days PTO, paid holidays, wellness perks.
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