Senior Manager, Global Regulatory Affairs (AI/ML)

Location: US Remote; compensation range specified for US-based candidates

Salary: $170,000–$200,000 per year, plus potential equity compensation.

Company

Hims & Hers is a public health and wellness platform providing personalized access to healthcare from diagnosis through treatment and delivery.

What you will do

• Own global regulatory strategy for software and AI/ML-enabled products across US and international markets.
• Partner with Product, Engineering, Clinical, Quality, and Legal teams on product strategy and regulatory decisions.
• Advise on emerging AI/ML, digital health, software, and cybersecurity requirements.
• Build governance frameworks for AI/ML product changes, algorithm monitoring, software lifecycle requirements, and cybersecurity.
• Identify regulatory risks and opportunities and translate regulatory developments into practical business recommendations.
• Make complex regulatory requirements understandable and actionable for cross-functional and executive stakeholders.

Requirements

• 12+ years of experience 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 regulatory frameworks and standards covering AI/ML, software lifecycle, risk management, quality systems, and cybersecurity.
• Ability to evaluate risk, make decisions with imperfect information, and provide practical business recommendations.
• Experience influencing Product, Engineering, Clinical, Quality, Legal, and executive stakeholders.
• BSc or MSc in Biomedical Engineering, Computer Science, Data Science, Software Engineering, or a related field required.

Nice to have

• Advanced degree such as an MS, PhD, or JD.
• RAC certification.

Culture & Benefits

• Full-time employment with competitive salary and equity compensation.
• Unlimited paid time off, company holidays, and quarterly mental health days.
• Medical, dental, and vision coverage with parental leave.
• Employee Stock Purchase Program and 401(k) with employer matching contributions.
• Offsite team retreats and a flexible remote work approach.