Sr Manager, Global Regulatory Affairs (AI/ML)

US - Remotefull timeRemote

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senior

$170k–$200k

H1B: no

Hims and Hers Senior Manager, Global Regulatory Affairs (AI/ML) at Hims and Hers leading global regulatory strategy for software, AI/ML-enabled products, and cybersecurity requirements. Collaborates cross-functionally to navigate regulatory risks and create practical pathways for product development.

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.
Bring deep subject matter expertise while making complex regulatory requirements understandable and actionable for teams across Hims & Hers

Qualification

Ability to evaluate riskBSc or MSc in Biomedical Engineering

Required

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.
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.