Senior Manager, Global Regulatory Affairs — AI/ML

Jobicy; United States; Remote; USD 180,000 - 260,000; Full time

Benefits offered by this job

Competitive salary & equity

Unlimited PTO

Health benefits including medical, and

Employee Stock Purchase Program (ESPP)

401k with employer matching

Offsite team retreats

Job summary

Hims & Hers seeks a Senior Manager, Global Regulatory Affairs (AI/ML) to lead regulatory strategy across a global health and wellness platform. You will work with Product, Engineering, Clinical, Quality, and Legal to shape strategy early, navigate evolving regulatory questions, and craft practical paths forward.

You will bring 12+ years in Regulatory Affairs with deep digital health and AI/ML expertise, engaging FDA/international regulators and translating complex requirements into actionable

Qualifications

• 12+ years in Regulatory Affairs with focus on digital health and AI/ML.
• Direct experience engaging the FDA and international authorities on software/AI/ML products.
• Knowledge of global regulatory frameworks for AI/ML, software lifecycle, risk management, quality systems, cybersecurity.
• Ability to translate evolving requirements into clear, practical business recommendations.
• Influence Product, Engineering, Clinical, Quality, Legal, and executives with regulatory concepts.
• Comfort moving between strategy and hands-on execution in a fast-paced environment.

Responsibilities

• Own global regulatory strategy for software and AI/ML products across US and international markets.
• Partner with Product, Engineering, Clinical, Quality, and Legal to shape strategy early.
• Advise on AI/ML, digital health, and cybersecurity requirements and translate changes into actionable guidance.
• Build scalable regulatory governance for AI/ML product changes, monitoring, and cybersecurity.
• Identify regulatory risks and guide decisions when paths forward are unclear.
• Monitor global regulatory developments to position the business for upcoming changes.
• Make complex regulatory concepts understandable across teams.

Skills

Regulatory leadership

Digital health

AI/ML regulatory

FDA engagement

Cross-functional influence

Regulatory strategy

Risk management

Education

BSc/MSc in Biomedical Eng / CS

Job description

Hims & Hers seeks a Senior Manager, Global Regulatory Affairs (AI/ML) to lead regulatory strategy across a global health and wellness platform. You will work with Product, Engineering, Clinical, Quality, and Legal to shape strategy early, navigate evolving regulatory questions, and craft practical paths forward.

You will bring 12+ years in Regulatory Affairs with deep digital health and AI/ML expertise, engaging FDA/international regulators and translating complex requirements into actionable