Global Regulatory Strategy Lead - AI/ML

Hims, Inc.; Northern (KY); Hybrid; USD 150,000 - 210,000; Full time

Benefits offered by this job

Competitive salary and equity

Unlimited PTO and holidays

Comprehensive health benefits

Employee Stock Purchase Program

401k with match

Offsite team retreats

Job summary

Hims & Hers is seeking a Senior Manager, Global Regulatory Affairs (AI/ML) to lead regulatory strategy for software, AI/ML-enabled products, and cybersecurity across US and international markets.

You will collaborate with Product, Engineering, Clinical, Quality, and Legal teams to shape strategy early, translate regulatory questions into actionable paths, and balance speed with risk in a fast-paced environment.

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, 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.

Responsibilities

• 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.

Skills

Regulatory leadership

AI/ML regulatory

Cross-functional collaboration

Regulatory strategy

Risk assessment

Executive communication

Regulatory influence

Education

Biomedical Eng/CS/Data Sci

Advanced degree RAC valued

Job description

Hims & Hers is seeking a Senior Manager, Global Regulatory Affairs (AI/ML) to lead regulatory strategy for software, AI/ML-enabled products, and cybersecurity across US and international markets.

You will collaborate with Product, Engineering, Clinical, Quality, and Legal teams to shape strategy early, translate regulatory questions into actionable paths, and balance speed with risk in a fast-paced environment.