Sr Manager, Global Regulatory Affairs (AI/ML)

The role

You will own global regulatory strategy for software, AI/ML-enabled products, and cybersecurity requirements. You will work with Product, Engineering, Clinical, Quality, and Legal teams to navigate regulatory risks and shape product strategy.

What you will do

• Own global regulatory strategy for software and AI/ML-enabled products across US and international markets.
• Serve as a regulatory partner across Product, Engineering, Clinical, Quality, and Legal teams.
• Advise teams on emerging AI/ML, digital health, and cybersecurity requirements.
• Build scalable regulatory and governance frameworks for AI/ML product changes and cybersecurity.
• Identify regulatory risks and opportunities early.
• Monitor global regulatory developments to position the business for upcoming changes.
• Make complex regulatory requirements understandable and actionable for teams.

Required 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 and make decisions with imperfect information.
• Demonstrated capability to influence Product, Engineering, Clinical, Quality, Legal, and executive stakeholders.
• Strong ownership with comfort moving between strategy and hands-on execution.
• BSc or MSc in Biomedical Engineering, Computer Science, Data Science, Software Engineering, or a related field required.

Nice to have

• advanced degree (MS, PhD, JD)
• RAC

Benefits

• Competitive salary & equity compensation
• Unlimited PTO
• company holidays
• quarterly mental health days
• Comprehensive health benefits including medical, dental & vision
• parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats

About the company

Hims & Hers is a health and wellness platform that provides access to personalized care. It is a public company traded on the NYSE.