FDA Regulatory Consultant (SaMD / AI-ML Medical Devices)

Location: Remote / US-based (US Citizen or Permanent Resident)

Type: Part-Time Consultant with Key Personnel Option

Compensation (conditional on award):

• $200-300/hr consultant retainer (experience-dependent)
• Option to convert to 0.3 FTE Key Personnel (~$10,000-15,000/month)

⏳ TIMING: This is a post-award role. We are currently applying for ARPA-H ADVOCATE funding (decision expected Q2 2026). We're building our pipeline now for rapid engagement if awarded.

Interested? Express interest now; we'll reach out when funding is confirmed.

The Opportunity

Regain is applying for the ARPA-H ADVOCATE Program, a $50M+ federal initiative to create the first FDA-authorized autonomous AI for cardiovascular care.

Most teams applying for ADVOCATE are proposing to build. We're demonstrating working software:

Total regulatory budget across both TAs: ~$1.65M over 39 months. This role shapes the FDA strategy for all of it.

Why This Is Unlike Any SaMD Filing You've Done

You're not filing a 510(k) for a diagnostic app or a remote monitoring tool. You're defining the FDA pathway for autonomous clinical AI that generates medication orders, a category that doesn't exist in FDA's classification system today.

Here's what makes it unusual:

Deutsch isn't clinical decision support. It generates protocol-bound medication proposals for GDMT titration (ARNI, beta-blockers, MRAs, SGLT2i, statins, anticoagulants) that route through clinician governance and TA2 safety supervision before reaching an EHR signature workflow. The intended use statement reads: "autonomous, guideline-concordant cardiovascular medication management and monitoring for adult patients with HF, post-MI, HTN, HLD, and AFib under clinician protocol governance and independent TA2 safety supervision." No predicate device exists for this.

Popper isn't another AI watching an AI. It's a deterministic policy engine. Same input + same policy pack = same decision, every time. No LLMs, no stochastic outputs, no drift in the safety path. The MDDT qualification would establish a new federal standard for evaluating AI safety monitoring.

Both systems already work. Deutsch manages 4,000+ patients in production. Popper's 7-gate pipeline runs in 47ms. The pre-clinical evaluation framework covers 68 clinical vignettes across 8 CVD conditions with 6 deterministic scoring layers mapping directly to ARPA-H metrics. You'd be defining regulatory strategy for production software, not reviewing a research prototype.

The Dual-Track Regulatory Challenge

This role requires a dual-track FDA strategy spanning two technical areas on a single program:

TA1: Deutsch CVD Agent, De Novo + Breakthrough Device

Key design features you'll need to understand and articulate to FDA:

• ArgMed debate architecture: three agents generating, critiquing, and selecting clinical hypotheses using Hard-to-Vary (HTV) epistemic scoring (≥0.7 threshold to proceed, <0.3 to reject)
• IDK Protocol: 12 distinct trigger types for honest uncertainty admission. When the system doesn't know, it says so and routes to a clinician
• Engine + Cartridge separation: disease-agnostic reasoning engine with swappable disease-specific cartridges. Supports a PCCP for AI/ML updates without re-submission
• Two-site clinical validation: UI Health (Chicago, safety-net, 70% minority) and UCHealth/CU Anschutz (rural + Medicaid). Two EHR integrations, two patient populations, blinded non-inferiority assessment against board-certified cardiologist panel

TA2: Popper Supervisory Agent, MDDT Qualification

MDDT category and Context of Use to be confirmed with FDA during the Phase 1A pre-submission meeting. We anticipate Non-Clinical Assessment Model (NAM) based on Popper's function as a software tool evaluating other AI system outputs.

Key regulatory features:

• Deterministic safety DSL: versioned policy rules with semver tracking. Every safety decision cites which rules fired and why
• Cross-performer validation: Popper monitors any Hermes-compliant TA1 regardless of architecture, LLM stack, or reasoning approach. A qualified MDDT becomes a tool any TA1 developer can reference in their own submissions
• Non-bypassability: TA1 output is never rendered to the patient unless Popper returns APPROVED with a valid audit ID. Enforced architecturally, not by convention
• Regulatory export bundles: de-identified audit packages (HIPAA-compliant, Expert Determination) ready for FDA review

Scope of Work

Phase 1A (12 months): Foundation

TA1 regulatory (~800 consultant hours budgeted):

• Lead Pre-Submission (Q-Sub) meeting strategy with FDA
• Prepare and submit 513(g) Request for Information
• Draft and submit BDD application
• Define De Novo regulatory roadmap for autonomous prescribing SaMD
• Advise on QMS framework (ISO 13485, IEC 62304)
• Risk analysis across the ArgMed architecture, GDMT titration protocols, and two-site deployment

TA2 regulatory (~285 consultant hours budgeted):

• Prepare MDDT Letter of Intent
• FDA pre-submission meeting support
• MDDT engagement strategy and category/COU analysis
• QMS documentation for safety supervision

Phase 1B (12 months): Submissions

• Lead 513(g) submission and De Novo preparation
• BDD follow-up and FDA feedback incorporation
• MDDT qualification package development for TA2 (evidence package: >95% accuracy, >97% acuity detection)
• Support multi-site clinical validation regulatory requirements (500+ patients at UI Health, 150+ at UCHealth)

Phase 2 (15 months): Authorization

• De Novo submission for TA1
• FDA follow-up and response
• MDDT qualification submission for TA2
• Post-market regulatory planning and scalability (I-I-CAPTAIN 5-hospital network deployment)

Requirements

Must-Have

• 5+ years FDA regulatory affairs experience
• Led or contributed significantly to at least one SaMD submission (510(k) or De Novo)
• US Citizen or Permanent Resident
• Available starting Q3 2026 (contingent on award)

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

• MDDT qualification experience
• Reimbursement or market access background
• Health system or payer relationships
• Familiarity with USCDI / TEFCA interoperability standards

Why This Role Matters

Clinical Sites

Next Steps

This is a post-award role. We're building our pipeline now for rapid engagement if ARPA-H selects us (decision expected Q2 2026).

To express interest, email anton@regain.ai with:

1. Brief background on your SaMD regulatory experience
2. Relevant De Novo, BDD, or MDDT experience (if any)
3. Your preferred engagement model and rate expectations

We'll follow up when funding is confirmed.