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Director of Regulatory Affairs

On-site Full-time

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Experience Level

Senior Level Manager

Qualifications

Key ResponsibilitiesLead regulatory strategy development and execution for clinical trials and AI-driven products. Draft regulatory documents and establish processes for compliance. Coordinate cross-departmental activities to align regulatory objectives. Interface with client regulatory teams to ensure successful AI deployment.

About the job

About Us

Hippocratic AI stands at the forefront of generative AI technology in the healthcare sector. We proudly offer the only system capable of conducting safe and autonomous clinical conversations with patients. Our Polaris constellation includes proprietary LLMs that achieve an impressive accuracy rate exceeding 99.9%.

Why Join Our Team

Transform healthcare with a safety-first AI approach. We are pioneering the world’s first healthcare-exclusive, safety-oriented LLM, designed to revolutionize patient outcomes on a global scale. This is an opportunity to create a new category in the industry.

Collaborate with industry visionaries. Our company was co-founded by CEO Munjal Shah alongside a team of esteemed physicians, hospital executives, AI innovators, and researchers from renowned institutions, including El Camino Health, Johns Hopkins, Washington University in St. Louis, Stanford, Google, Meta, Microsoft, and NVIDIA.

Supported by top-tier investors. Recently, we secured $126 million in Series C funding at a valuation of $3.5 billion, led by Avenir Growth, bringing our total funding to $404 million with contributions from CapitalG, General Catalyst, a16z, Kleiner Perkins, Premji Invest, UHS, Cincinnati Children’s, WellSpan Health, John Doerr, Rick Klausner, and others.

Grow with the best in healthcare and AI. Join a team of experts dedicated to enhancing care, advancing scientific knowledge, and developing transformative technologies that ensure our platform is both powerful and trustworthy.

Location Requirement

We believe that the best ideas emerge through collaboration. To foster rapid teamwork and a strong organizational culture, this position is expected to be based in our Palo Alto office five days a week unless otherwise noted.

About the Role

The Director of Regulatory Affairs will spearhead the development and execution of both global and domestic regulatory strategies, filings, and compliance initiatives for (a) clinical trials involving pharmaceuticals, biologics, and medical devices, and (b) AI-driven software as a medical device (SaMD) products. This role seeks an experienced regulatory practitioner who is well-versed in FDA culture and regulatory guidelines and can translate that knowledge into actionable processes, document preparation, and cross-functional collaboration. Ideal candidates will effectively engage with our clients' regulatory teams to ensure congruity and successful integration of our AI solutions within the pharmaceutical and medtech sectors. Reporting directly to the General Counsel, this position will closely collaborate with our legal, pharmaceutical, clinical, and IT teams.

About Hippocratic AI

Hippocratic AI is revolutionizing the healthcare landscape through innovative AI solutions that prioritize patient safety. With a robust backing from leading investors and a team comprised of distinguished professionals, we are committed to enhancing healthcare outcomes globally.

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