Head of Regulatory Affairs for AI SaMD & Quality

Hippocratic AI Inc.; Menlo Park (CA); On-site; USD 180,000 - 270,000; Full time

Job summary

Hippocratic AI Inc. is seeking a Head of Regulatory Affairs and Quality Control to lead global regulatory strategy and ensure compliance for AI-driven SaMD products. You will draft documents, build processes, and coordinate cross‑functional teams across clinical, engineering, and quality functions.

The role requires deep FDA knowledge, experience with INDs/NDAs/510(k)s, and a track record of navigating fast‑paced startup environments. Join a team transforming healthcare safety with AI.

Qualifications

• 8+ years of regulatory affairs experience spanning medical devices and digital health.
• Bachelor’s degree in life science required.
• Experience interfacing with FDA and deep regulatory knowledge.
• Strong understanding of clinical trials, drug/device development, post‑market activities.

Responsibilities

• Lead regulatory strategy and submissions for AI-enabled SaMD products (NDAs, De Novo, 510(k)).
• Develop regulatory documentation enabling customers in pharma/medtech space to meet compliance.
• Prepare regulatory submissions with Legal: sections, data inputs, timelines, high‑quality docs.
• Translate regulatory requirements into actionable tasks for clinical, product, engineering, and quality teams.
• Oversee global/regulatory initiatives, manage risk, ensure alignment with evolving expectations.

Skills

Regulatory strategy

Regulatory submissions

FDA interfacing

Cross-functional leadership

Regulatory documentation

Risk management

Regulatory training

Communication with FDA

Education

Bachelor’s degree in life science

PhD/PharmD/Master’s degree preferred

Job description

Hippocratic AI Inc. is seeking a Head of Regulatory Affairs and Quality Control to lead global regulatory strategy and ensure compliance for AI-driven SaMD products. You will draft documents, build processes, and coordinate cross‑functional teams across clinical, engineering, and quality functions.

The role requires deep FDA knowledge, experience with INDs/NDAs/510(k)s, and a track record of navigating fast‑paced startup environments. Join a team transforming healthcare safety with AI.