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Hims And Hers

Sr Manager, Global Regulatory Affairs (AI/ML)

Who can apply: US-based role. The employer has not said which states are eligible — confirm before applying.
Location as listed by the employer: “US - Remote”
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About this role

Hims And Hers is hiring for a Sr Manager, Global Regulatory Affairs (AI/ML) role (full-time). See the official posting for full details.

Requirements

  • 12+ years in Regulatory Affairs with dedicated depth in digital health and AI/ML.
  • Direct experience engaging the FDA and international regulatory authorities on complex software and AI/ML products.
  • Deep knowledge of global regulatory frameworks and standards governing AI/ML, software lifecycle, risk management, quality systems, and cybersecurity.
  • Ability to evaluate risk, make decisions with imperfect information, and translate evolving requirements into clear, practical business recommendations.
  • Demonstrated capability to influence Product, Engineering, Clinical, Quality, Legal, and executive stakeholders, making technical regulatory concepts accessible across teams.
  • Strong ownership with comfort moving between strategy and hands-on execution in a fast-paced environment.
  • BSc or MSc in Biomedical Engineering, Computer Science, Data Science, Software Engineering, or a related field required; advanced degree (MS, PhD, JD) or RAC valued.

Summarized from the employer's posting — check the full posting for every requirement.