Regulatory Affairs & FDA Submissions Subject-Matter Expert

Keep our medical software and device work correct on the regulatory pathway — what FDA will require, in what order, and what it will cost. What you'll do:

• Map the regulatory pathway for a proposed capability and say what evidence each step demands
• Advise on Software as a Medical Device, clinical decision support boundaries and predicate strategy
• Review our quality-system and documentation approach against what an auditor expects
• Tell us when a claim we want to make would change the device classification

Required:

• Direct experience preparing or supporting FDA submissions — 510(k), De Novo, PMA, IDE or IND
• Working knowledge of Software as a Medical Device and applicable FDA guidance
• U.S. citizen or lawful permanent resident (U.S. person)
• Willing to be named on a federal proposal with a one-page resume, and to sign a short letter of commitment

Preferred:

• Regulatory Affairs Certification (RAC) or equivalent
• ISO 13485, IEC 62304 or 21 CFR Part 820 quality systems
• AI/ML-enabled device experience and the Predetermined Change Control Plan framework
• BARDA, MTEC, DHA or comparable federal medical program experience