Sr Manager, Global Regulatory Affairs (AI/ML)

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. 

Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals.

As Hims & Hers continues to expand how we use software, AI, and machine learning across our healthcare platform, we are looking for a Senior Manager, Global Regulatory Affairs (AI/ML) to lead regulatory strategy for these rapidly evolving areas.

This role, you will own global regulatory strategy for software, AI/ML-enabled products, and cybersecurity requirements, helping teams understand what is possible, where regulatory risk exists, and how we can responsibly bring new capabilities to market. You will work closely with Product, Engineering, Clinical, Quality, and Legal teams to shape product strategy early, navigate complex regulatory questions, and create practical paths forward.

This is a highly cross-functional role for someone who combines deep regulatory expertise with strong judgment and business instincts. You are comfortable working in areas where regulation and technology are evolving quickly, can make complex topics simple, and know how to balance speed, innovation, and risk. You thrive in ambiguity and can move between setting strategy and getting into the details when needed.

• 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

• 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.

• 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.