Hims & Hers
Sr Manager, Global Regulatory Affairs (AI/ML)
$170K–$200K
US - Remote · Remote · Manager · Full-time · Posted Sep 25, 2026
- Experience
- 12+ years in Regulatory Affairs with dedicated depth in digital health and AI/ML.
- Education
- BSc or MSc in Biomedical Engineering, Computer Science, Data Science, Software Engineering, or a related field required.
About the job
Leads global regulatory strategy for software and AI/ML-enabled healthcare products, advising teams on requirements, risks, governance, and paths to market.
What you'll do
- Develop regulatory strategies and practical market pathways for software and AI/ML products across US and international markets.
- Advise cross-functional teams on AI/ML, digital health, and cybersecurity requirements and translate regulatory changes into actionable business guidance.
- Build regulatory and governance frameworks for AI/ML changes, algorithm monitoring, software lifecycle requirements, and cybersecurity.
What they ask for
- 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 for AI/ML, software lifecycle, risk management, quality systems, and cybersecurity.
- 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) or RAC.
Pay
$170K – $200K (base salary)
Tools
AI/ML, software, cybersecurity
AI focus
Sets regulatory strategy and governance for AI/ML-enabled products, including product changes and ongoing algorithm monitoring and evolution.
Model-written summary · the original posting is authoritative