Global Regulatory Strategy Lead - AI/ML Software

hims-and-hers; United States; Remote; USD 180,000 - 240,000; Full time

Benefits offered by this job

Competitive salary & equity

Unlimited PTO

Comprehensive health benefits

ESPP

401k with employer matching

Offsite team retreats

Job summary

Hims & Hers, a health and wellness platform, seeks a Senior Manager of Global Regulatory Affairs (AI/ML) to lead regulatory strategy for software, AI/ML-enabled products, and cybersecurity. You will partner with Product, Engineering, Clinical, Quality, and Legal to shape strategy, navigate evolving regulations, and ensure compliant, rapid product advancement.

You will own cross-border regulatory activities, monitor global developments, and translate complex requirements into actionable plans,

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.
• Bachelor/Master level degrees in relevant fields; advanced degrees or RAC valued.

Responsibilities

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

Skills

Regulatory strategy

FDA engagement

AI/ML regulatory

Cybersecurity regulatory

Risk assessment

Cross-functional leadership

Regulatory governance

Education

BSc or MSc in Biomedical Engineering, Computer Science, Data Science, Software Engineering, or related field

Advanced degree (MS, PhD, JD) or RAC valued

Job description

Hims & Hers, a health and wellness platform, seeks a Senior Manager of Global Regulatory Affairs (AI/ML) to lead regulatory strategy for software, AI/ML-enabled products, and cybersecurity. You will partner with Product, Engineering, Clinical, Quality, and Legal to shape strategy, navigate evolving regulations, and ensure compliant, rapid product advancement.

You will own cross-border regulatory activities, monitor global developments, and translate complex requirements into actionable plans,