SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
Hippocratic AI is a generative AI company focused on healthcare, building the first healthcare-only, safety-focused LLM system capable of safe, autonomous clinical conversations with patients. The company recently raised $126M in Series C funding at a $3.5B valuation.
As Head of Regulatory Affairs, you will lead global and domestic regulatory strategy, filings, and compliance for clinical trials (pharmaceuticals, biologics, medical devices) and AI-driven Software as a Medical Device (SaMD) products. This is a hands-on leadership role requiring deep FDA expertise and the ability to operationalize regulatory frameworks across the organization.
Key responsibilities include:
**Regulatory Strategy & Execution:** Develop and support regulatory strategies for AI-enabled SaMD products, including classification, marketing applications (NDAs, De Novo, 510(k)), and pre-submission pathways. Lead hands-on preparation of regulatory submissions, drafting documentation, coordinating data inputs, and managing timelines. Translate regulatory requirements into actionable tasks for clinical, product, engineering, and quality teams. Oversee global regulatory initiatives while managing risk and maintaining alignment with evolving regulatory expectations.
**Regulatory Compliance:** Build and manage a practical compliance structure across SaMD development lifecycles. Collaborate cross-functionally to ensure compliance with 21 CFR Parts 210/211, 21 CFR Part 820, SaMD guidance, AI/ML-specific expectations, cybersecurity, and labeling requirements. Design and maintain compliant frameworks including SOPs, controlled documents, audit readiness materials, and inspection response processes. Stay ahead of evolving policies and draft internal guidance. Interface with customer regulatory leads to facilitate deployment.
**Cross-Functional Leadership:** Partner with legal, product, and engineering teams to define regulatory requirements early and de-risk strategy. Educate technical and clinical teams on FDA expectations and quality documentation needs. Drive internal regulatory training and provide clear guidance, templates, and timelines.
**Innovation & Process Building:** Build lightweight, startup-appropriate regulatory processes without sacrificing compliance. Use regulatory knowledge to enable innovation and speed while maintaining safety. Identify gaps and implement corrective actions proactively. Contribute to playbooks, templates, and scalable processes.
You will work closely with legal, pharma, clinical, and IT teams, and interface with customers' regulatory leads to ensure successful deployment of AI solutions in pharma and medtech.
