Sr Manager, Global Regulatory Affairs (AI/ML)

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 is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we're making better health outcomes easier to achieve.

Hims & Hers is a public company, traded on the NYSE under the ticker symbol "HIMS." To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works. For information on the company's outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals.

As Hims & Hers continues to expand how we use software, AI, and machine learning across our healthcare platform, we are looking for a Senior Manager, Global Regulatory Affairs (AI/ML) to lead regulatory strategy for these rapidly evolving areas.

This role, you will own global regulatory strategy for software, AI/ML-enabled products, and cybersecurity requirements, helping teams understand what is possible, where regulatory risk exists, and how we can responsibly bring new capabilities to market. You will work closely with Product, Engineering, Clinical, Quality, and Legal teams to shape product strategy early, navigate complex regulatory questions, and create practical paths forward.

This is a highly cross-functional role for someone who combines deep regulatory expertise with strong judgment and business instincts. You are comfortable working in areas where regulation and technology are evolving quickly, can make complex topics simple, and know how to balance speed, innovation, and risk. You thrive in ambiguity and can move between setting strategy and getting into the details when needed.

You Will

• 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

You Have

• 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.

You Have

• 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.

Our Benefits (there are more but here are some highlights):

• Competitive salary & equity compensation for full‑time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats

We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply - even if you're not sure if your background or experience is a perfect match.

Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at [e-mail] and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address.

To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement.