Part-Time Consultant → Key Personnel Option

Regain; Chicago (IL); Remote; USD 120.000 - 180.000; Teilzeit

Zusammenfassung

Regain is seeking an FDA regulatory consultant for a remote, US-based role to shape regulatory strategy for autonomous AI medical software. The position offers a part-time consultant engagement with the option to convert to 0.3 FTE, aligning with ARPA-H ADVOCATE program milestones and multi-site validation requirements.

The role requires leading submissions, defining De Novo pathways, and ensuring QMS alignment.

Qualifikationen

• 5+ years FDA regulatory affairs experience.
• Led or contributed to at least one SaMD submission.
• AI/ML medical device regulatory knowledge preferred; Breakthrough Device Designation experience preferred.

Aufgaben

• Lead Pre-Submission strategy with FDA.
• Prepare and submit regulatory submissions (513(g), De Novo, BDD).
• Define De Novo regulatory roadmap for autonomous prescribing SaMD.
• Advise on QMS documentation (ISO 13485, IEC 62304).

Kenntnisse

FDA regulatory affairs

SaMD submissions

AI/ML medical devices

Regulatory strategy

Jobbeschreibung

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 full-time equivalent (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.

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:

| System | What It Does | Status ||--------|-------------|--------|| Deutsch (cardiovascular agent; Technical Area 1, or TA1) | Autonomous cardiovascular care: three-agent clinical reasoning (ArgMed debate), protocol-bound guideline-directed medical therapy (GDMT) titration, multi-domain treatment plans across heart failure (HF), post-MI, hypertension (HTN), hyperlipidemia (HLD), and AFib | 100% core complete, 4,000+ patients in production || Popper (supervisory agent; Technical Area 2, or TA2) | Deterministic safety supervision: 7-gate pipeline gating every clinical output in 47ms. No large language models (LLMs) in the safety-critical path. Versioned policy rules, not neural networks | 100% core deployed || Hermes Protocol | Open-source TA1TA2 communication standard (Apache 2.0). Any TA1 works with any TA2. Conformance test suite included | Released Feb 5, 2026 |

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 (angiotensin receptor-neprilysin inhibitors, beta-blockers, mineralocorticoid receptor antagonists, SGLT2 inhibitors, statins, anticoagulants) that route through clinician governance and TA2 safety supervision before reaching an electronic health record (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 Medical Device Development Tool (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 cardiovascular 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:

| Milestone | Target | Budget ||-----------|--------|--------|| 513(g) Request for Information | Phase 1A, Month 6 | $100K (meeting prep) || Breakthrough Device Designation | Phase 1A, Month 9 | $75K (BDD application) || De Novo regulatory roadmap | Phase 1A | $100K (strategy) || Pre-submission meeting | Phase 1B, Month 18 | Included in Phase 1B || De Novo authorization submission | Phase 2 | $300K (Phase 2 regulatory) |

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)
• I-don't-know (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 predetermined change control plan (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

| Milestone | Target | Budget ||-----------|--------|--------|| MDDT Letter of Intent | Phase 1A | $50K (LOI prep) || FDA pre-submission meeting | Phase 1A | $40K (meeting support) || MDDT engagement strategy | Phase 1A | $35K || Qualification package development | Phase 1B | $250K || MDDT qualification submission | Phase 2 | $100K |

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 domain-specific language (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 Software as a Medical Device (SaMD)
• Advise on quality management system (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
• 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)

Strongly Preferred

• AI/ML medical device experience: familiarity with PCCP and Good Machine Learning Practice (GMLP)
• Digital health or cardiology device background
• BDD (Breakthrough Device Designation) experience
• Prior ARPA-H, NIH, or federal health grant experience

Nice-to-Have

• Reimbursement or market access background
• Health system or payer relationships
• Familiarity with United States Core Data for Interoperability (USCDI) / Trusted Exchange Framework and Common Agreement (TEFCA) interoperability standards

Why This Role Matters

| Benefit | Details ||---------|---------|| First of its kind | No one has filed a De Novo for autonomous prescribing AI. You'd be defining the regulatory pathway, not following one || Dual-track strategy | Shape both De Novo (TA1) and MDDT (TA2) simultaneously: two first-of-kind submissions under a single program || Production software | The systems already work. 4,000+ patients, 47ms safety supervision, 68-vignette evaluation framework. Your job is regulatory strategy, not waiting for engineering to catch up || $1.65M regulatory budget | Dedicated funding for regulatory activities across 39 months on a $19M+ combined federal award || Industry standard | A qualified MDDT and an open-source safety protocol (Hermes, Apache 2.0) would set standards that outlast the program |

Clinical Sites

| Site | Location | Population | EHR | Regulatory Relevance ||------|----------|-----------|-----|---------------------|| UI Health | Chicago, IL | Safety-net, 70% minority | Epic | Primary validation site. Equity demonstration for FDA || UCHealth/CU Anschutz | Aurora, CO | Rural + Medicaid | Epic | I-I-CAPTAIN network. Scalability evidence for De Novo |