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.
You Will- 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
You Have- 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.
You Have- 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.
Our Benefits (there are more but here are some highlights):- 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
