Sr. Software Regulatory Affairs Specialist

 What you'll do...

• 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.