Hims & Hers
Healthcare & Life SciencesDirect Ashby career site

Sr Manager, Global Regulatory Affairs (AI/ML)

Location
Remote (US)
Job type
Full-time
Level
Director
Experience
12+ years
Education
Bachelor's degree
Listed
23 days ago

Skills & highlights for this role

  • FDA regulatory submissions
  • software lifecycle compliance
  • AI/ML regulatory frameworks

Also useful

  • RAC certification
  • cybersecurity regulatory standards
  • risk management (ISO 14971)

Stated benefits & perks

  • Medical
  • Dental
  • Vision
  • 401k match
  • Unlimited pto

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.

Benefits

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.

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.

  • If you need assistance or an accommodation due to a disability, please contact us at 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.
  • Please do not send resumes to this email address.

About Hims & Hers

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.

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.

Equal opportunity and legal notices

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.

Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability.

Read the original posting

From Hims & Hers's careers page, first listed on Rolev.ai on October 17, 2026. Rolev.ai is not the employer.

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Common questions

Where is the Sr Manager, Global Regulatory Affairs (AI/ML) job at Hims & Hers located?

Yes, this Sr Manager, Global Regulatory Affairs (AI/ML) opening at Hims & Hers is listed as Remote (US). Always check Hims & Hers's application page for specific state eligibility or relocation policies.

What qualifications are required for Sr Manager, Global Regulatory Affairs (AI/ML) at Hims & Hers?

For the Sr Manager, Global Regulatory Affairs (AI/ML) role, Hims & Hers highlights 12+ years of relevant experience; a bachelor's degree; experience with FDA regulatory submissions, software lifecycle compliance, AI/ML regulatory frameworks. Rolev.ai can score your existing resume against these requirements and show any skill gaps before you apply.

How do I apply for the Sr Manager, Global Regulatory Affairs (AI/ML) position at Hims & Hers?

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