Senior Business Development Leader

Business Development Founding Team Atlanta-preferred
· Remote (US) Full-time

Healthcare AI / Regulated Markets — Reports to Founder / CEO

Precoh turns AI regulation into real-world deployment. Our platform,
RegOS
, transforms fragmented regulatory requirements (FDA SaMD, EU MDR, IMDRF) into structured, executable, and auditable workflows — so clinical AI can be evaluated, approved, and scaled with confidence.

Alongside RegOS, our advisory practice runs sandbox-readiness sprints, regulated-AI experiment design, and implementation pilots for three buyer types:

• Regulators and sandbox operators running consistent, reproducible evaluations across AI submissions.
• Health systems evaluating third-party AI before procurement and across the post-market lifecycle.
• AI and Med Tech companies running pre-submission evaluations before FDA or EU MDR filing.

We are early, founder-led, and revenue-generating. This is a foundational commercial role on our team.

The regulatory-AI market is forming in real time, and the buyers — Chief AI Officers, CMIOs, regulatory affairs leaders, sandbox operators — are sophisticated, technical, and skeptical of generic GTM motions. We are looking for a commercial leader who can sit across the table from a Chief AI Officer at a multi-hospital system, a regulator running a SaMD sandbox, and a clinical‑AI startup preparing for submission — and translate Precoh's regulatory infrastructure into structured pilots, signed engagements, and a repeatable pipeline.

This is a build-the-engine role. You will own the commercial motion end-to-end and grow a team underneath you.

• Stand up Precoh's commercial operating system: ICP definition, target-account list, CRM, outbound, deal stages, and forecast.
• Codify Precoh's service offerings into clean packages, scoping templates, and pricing playbooks.
• Run discovery with qualified buyers and produce written buyer‑insight memos that sharpen positioning, packaging, and pricing.
• Own a self-sourced pipeline and convert it across health systems, regulators / sandbox operators, and AI/Med Tech vendors.
• Lead complex, multi‑stakeholder pursuits across Chief AI Officers, regulatory affairs, IT/security, procurement, and clinical leadership.
• Land and shape design‑partner engagements with regulators and sandbox operators.
• Partner with the founder on category creation: thought‑leadership, conference presence (HIMSS, RSNA, Adva Med, FDA workshops), and analyst briefings.
• Hire and ramp the next commercial roles (BD/AE and a sales engineer / regulatory solutions lead) and build out a partner channel with QMS vendors, CROs, AI assurance firms, and advisory practices.

• Run technical discovery — confidently discuss FDA SaMD risk classes, 510(k) vs. De Novo, EU MDR Class IIa/IIb, predetermined change control plans (PCCPs), Good Machine Learning Practice (GMLP), bias and fairness evaluation, post‑market surveillance, and AI assurance frameworks (NIST AI RMF, ISO/IEC 42001, IMDRF).
• Translate buyer pain into RegOS evaluation scope, evidence packages, and decision artifacts.
• Build proposals, MSAs, and SOWs alongside the founder; negotiate pricing, success criteria, and data‑use terms.
• Maintain a live point of view on the competitive landscape — AI assurance startups, QMS vendors, advisory practices, and academic evaluation labs.
• Run the deal desk: forecast accuracy, pipeline hygiene, and weekly commercial reviews.
• Produce written artifacts — buyer memos, deal reviews, win/loss analyses — at a level that ships externally.

• 8+ years in business development, commercial strategy, or GTM leadership, with at least 3 years selling a technical product or advisory service into healthcare, life sciences, or another regulated industry
  .
• Demonstrated wins with one or more of: US health systems / academic medical centers, regulators or sandbox operators, AI/Med Tech companies, or pharma R&D and clinical operations.
• Working fluency in regulated‑AI vocabulary: SaMD, FDA premarket pathways, EU MDR, IMDRF, clinical validation, model risk management, AI governance, bias/fairness,…