Senior Manager, Global Regulatory Affairs – AI/ML

. Own global regulatory strategy for software and AI/ML-enabled products across US and international markets .

Posted 9/25/2026full-timeRemote • United StatesSenior💰 $170,000 - $200,000 per yearWebsite

Tools & technologies

Cyber Security

Key responsibilities & impact

Own global regulatory strategy for software and AI/ML-enabled products across US and international markets
Develop practical regulatory pathways balancing patient, product, and business risk
Serve as a regulatory partner to Product, Engineering, Clinical, Quality, and Legal teams
Advise on emerging AI/ML, digital health, and cybersecurity requirements
Translate regulatory changes into clear implications and business recommendations
Build regulatory and governance frameworks for AI/ML product changes, algorithm monitoring, software lifecycle requirements, and cybersecurity
Identify regulatory risks and opportunities early
Monitor global regulatory developments and champion policies supporting future offerings
Make complex regulatory requirements understandable and actionable across the organization

What you’ll need

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
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
Legally authorized to work in the U.S. without restriction for any employer
Must not require immigration sponsorship by Hims & Hers to work in the U.S.

Comp & perks