Hippocratic AI has developed a safety-focused Large Language Model (LLM) for healthcare. The company believes that a safe LLM can dramatically improve healthcare accessibility and health outcomes in the world by bringing deep healthcare expertise to every human. No other technology has the potential to have this level of global impact on health.
Innovative Mission: We are developing a safe, healthcare-focused large language model (LLM) designed to revolutionize health outcomes on a global scale.
Visionary Leadership: Hippocratic AI was co-founded by CEO Munjal Shah, alongside a group of physicians, hospital administrators, healthcare professionals, and artificial intelligence researchers from leading institutions, including El Camino Health, Johns Hopkins, Stanford, Microsoft, Google, and NVIDIA.
Strategic Investors: We have raised a total of $278 million in funding, backed by top investors such as Andreessen Horowitz, General Catalyst, Kleiner Perkins, NVIDIAs NVentures, Premji Invest, SV Angel, and six health systems.
World-Class Team: Our team is composed of leading experts in healthcare and artificial intelligence, ensuring our technology is safe, effective, and capable of delivering meaningful improvements to healthcare delivery and outcomes.
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Location Requirement: This is a Palo Altobased role and requires working onsite five days a week . Only candidates who are currently local or willing to relocate will be considered.
The Head of Regulatory Affairs is responsible for leading and executing global and domestic regulatory strategy, filings, and compliance activities for (a) clinical trials for pharmaceuticals, biologics, and medical devices, and (b) AI-driven SaMD products. This role requires a practitioner who not only knows FDA culture and regulatory frameworks, but can also operationalize them, drafting documents, building processes, and coordinating crossfunctional activities. Successful candidates will be able to interface with our customers regulatory leads to ensure alignment and successful deployment of our AI in the pharma and medtech space. This role reports to the General Counsel, and will work closely with our legal, pharma, clinical, and IT teams.
Help develop and support regulatory strategies and submissions for AI-enabled SaMD products, including classification, marketing applications (e.g., NDAs, De Novo, 510(k)), and presubmission pathways.
Help develop and support regulatory documentation that enables our customers in the pharma and medtech space to meet their compliance obligations when using Hippocratic AIs products.
Lead handson preparation of regulatory submissions with Legal: drafting sections, coordinating data inputs, managing timelines, and ensuring highquality documentation.
Translate regulatory requirements into specific, actionable tasks for clinical, product, engineering, and quality teams.
Oversee and advance global and domestic regulatory and compliance initiatives, maintaining scientific accuracy, proactively managing risk, and keeping the organization aligned with changing regulatory expectations.
Build, manage, and continuously improve a practical regulatory compliance structure across SaMD development lifecycles.
Collaborate with legal, engineering, clinical, product, and quality teams to ensure compliance with applicable regulations, including 21CFR Parts210 and211, 21CFR Part820, SaMD guidance, AI/MLspecific expectations and guidance, cybersecurity, and labeling requirements.
Help design, support, and maintain a compliant regulatory framework and Pharmapartner guidelines, including iterative AI development, model updates, QMS and GMP requirements, audits and inspections, realworld performance, and postmarket monitoring and mitigation.
Develop and maintain SOPs, controlled documents, audit readiness materials, and inspection response processes.
Stay ahead of evolving regulatory policies and draft internal guidance to translate new requirements into clear action for crossfunctional teams.
Interact with customer regulatory leads to facilitate deployment of Hippocratics solutions with customers in the pharma and medtech industry.
Partner with legal, product, and engineering teams during development to define regulatory requirements early and derisk product strategy.
Educate technical and clinical teams on regulatory expectations, FDA and pharmaceutical industry norms, and quality documentation needs.
Drive internal regulatory training and ensure that crossfunctional teams have clear guidance, templates, timelines, and expectations.
Bring creative, practical solutions to regulatory challenges inherent in AI technology in the healthcare space.
Build lightweight regulatory processes appropriate for a startup environment without sacrificing compliance.
Use regulatory knowledge to enable innovation, not block it - finding pathways that support speed, safety, and responsible AI.
Identify gaps in regulatory readiness and implement corrective actions proactively.
Contribute to internal playbooks, templates, and scalable processes across regulatory and compliance functions.
1012 years of regulatory affairs experience spanning medical devices, digital health, pharmaceuticals, and related FDAregulated products.
Bachelors degree in life science required.
Experience working at the FDA or directly interfacing extensively with FDA. Strong experience with FDA regulations and regulatory landscape.
Strong understanding of industry, including clinical trials, drug and device development, patient support services, ad/promo, pharmacovigilance, and postmarket activities.
Demonstrated experience preparing and submitting INDs, NDAs/BLAs, 510(k)s, De Novos, PMAs, supplements, and/or Qsubs.
Strong experience with drug, device, and SaMD development, submissions, and regulatory pathways.
Familiarity with AIenabled medical technologies, machine learning considerations, and evolving FDA expectations for AI/ML.
Demonstrated ability to thrive in fastpaced, dynamic startup environments with limited structure and high ownership.
Excellent written and verbal communication skills, especially for FDA submissions and internal education.
Experience working in a startup or emerginggrowth private company.
Prior leadership experience building regulatory frameworks or managing crossfunctional initiatives.
PhD, PharmD or Masters degree preferred. RAC certification or equivalent is a plus.
A regulatory leader who combines strategic thinking with detailed operational followthrough.
Someone who respects regulatory structure but is creative, innovative, and solutionsoriented.
A builder who wants to create the regulatory foundation for both advanced AI systems and traditional drug/device programs.
A collaborator who can work seamlessly with clinical, technical, product, and executive teams.
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