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Sr Manager, Global Regulatory Affairs (AI/ML)

Hims & Hers· POLICY
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Remote$170k - $200kFull-timePosted 3w ago

About the role

Senior leadership role owning global regulatory strategy for software, AI/ML-enabled products, and cybersecurity requirements across US and international markets; cross-functional partner to Product, Engineering, Clinical, Quality, and Legal to chart regulatory pathways for AI/ML and digital health initiatives.

Responsibilities

  • Own global regulatory strategy for software and AI/ML-enabled products across US and international markets, developing practical pathways that enable Hims & Hers to move quickly while balancing patient, product, and business risk
  • Serve as a trusted regulatory partner across Product, Engineering, Clinical, Quality, and Legal teams to shape strategy early, navigate ambiguity, and bring clear, actionable points of view to high-priority initiatives
  • Advise teams on emerging AI/ML, digital health, and cybersecurity requirements and translate regulatory changes into clear implications and recommendations for the business
  • Build scalable regulatory and governance frameworks for AI/ML product changes, ongoing algorithm monitoring and evolution, software lifecycle requirements, and cybersecurity
  • Identify regulatory risks and opportunities early and help teams make thoughtful decisions when the path forward is not obvious
  • Proactively monitor global regulatory developments to position the business for upcoming changes affecting tech, products, or growth strategy—including championing policies that enable future offerings
  • Bring deep subject matter expertise while making complex regulatory requirements understandable and actionable for teams across Hims & Hers

Qualifications

  • 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.

Skills

Required:Regulatory strategy for software and AI/MLFDA and international regulatory engagementRegulatory framework developmentCross-functional collaboration

Benefits

  • Competitive salary & equity compensation for full-time roles
  • Unlimited PTO, company holidays, and quarterly mental health days
  • Comprehensive health benefits including medical, dental & vision, and parental leave
  • Employee Stock Purchase Program (ESPP)
  • 401k benefits with employer matching contribution
  • Offsite team retreats
Last updated Oct 21, 2026. Interested? Apply on the company site.

About Hims & Hers

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