FDA Regulatory Consultant (SaMD / AI-ML Medical Devices)
Location: Remote / US-based (US Citizen or Permanent Resident)
Type: Part-Time Consultant
Compensation:
- Phase 1 (Mar 2026): $4,000–6,000 for full proposal regulatory section (~15–20 hours)
- Phase 2 (Post-Award): $200–300/hr consultant retainer, option to convert to 0.3 FTE Key Personnel (~$10,000–15,000/month)
The Opportunity
Regain Health is applying for the ARPA-H ADVOCATE Program—a $50M+ federal initiative to create the first FDA-authorized autonomous AI for cardiovascular care.
Our Advantage: We have working software, not PowerPoint:
- TA1 CVD Agent (Deutsch): 100% core complete
- TA2 Supervisory Agent (Popper): 100% complete
- Preliminary regulatory strategy drafted
The Regulatory Challenge: This program requires a dual-track FDA strategy:
- TA1 (The Brain): SaMD authorization via De Novo pathway + Breakthrough Device Designation
- TA2 (The Shield): MDDT qualification establishing a new federal standard for AI safety monitoring
Timeline & Engagement
| Phase | Deadline | Scope | Hours |
|---|---|---|---|
| Full Proposal | Apr 1, 2026 | Detailed regulatory strategy section | 15–20 hrs |
| Phase 1A | Q3 2026 | FDA engagement (Pre-Sub, 513(g)) | Ongoing |
Current Need: We're building our pipeline for full proposal support starting March 2026. If you're interested, reach out now—we'll engage formally after our solution summary is submitted (Feb 27).
Scope of Work
Full Proposal (Mar–Apr 2026)
- Detailed regulatory strategy section
- Risk analysis and mitigation
- FDA interaction timeline
- QMS framework recommendations
Post-Award (If ARPA-H Selects Us)
- Lead Pre-Submission (Q-Sub) meeting strategy with FDA
- Define regulatory pathway for autonomous prescribing SaMD
- Support MDDT qualification strategy for TA2 Supervisory Agent
- Advise on QMS framework (ISO 13485, IEC 62304)
Requirements
Must-Have
- 5+ years FDA regulatory affairs experience
- Led or significantly contributed to at least one SaMD submission (510(k) or De Novo)
- US Citizen or Permanent Resident
- Available for 15–20 hours in March 2026
Strongly Preferred
- AI/ML medical device experience (PCCP, GMLP familiarity)
- Digital health or cardiology device background
- BDD (Breakthrough Device Designation) experience
- Prior ARPA-H, NIH, or federal health grant experience
Nice-to-Have (for post-award scope)
- MDDT qualification experience
- Reimbursement/market access background
- Health system or payer relationships
Why This Matters
| Benefit | Details |
|---|---|
| Defined Scope | 15–20 hours for full proposal regulatory section |
| Paid Work | $4,000–6,000 for full proposal support |
| Growth Potential | Expand to post-award engagement |
| Historic Impact | Help define FDA pathway for autonomous medical AI |
Next Steps
Timeline: We'll engage formally in early March after solution summary submission (Feb 27). Express interest now to be first in our pipeline.
To express interest, email with:
- Brief background on your SaMD regulatory experience
- Availability in March 2026
- Your hourly rate or project fee for full proposal support
Ready to Apply?
Send your resume directly to Anton Kim, Regain's founder and CEO.
