Sr Manager, Global Regulatory Affairs (AI/ML)

Hims & Hers; United States; Remote; USD 170,000 - 200,000; Full time

Benefits offered by this job

Equity

Unlimited PTO

Health benefits

ESPP

401k

Offsite team retreats

Job summary

Hims & Hers is seeking a Senior Manager, Global Regulatory Affairs (AI/ML) to lead regulatory strategy for AI/ML-enabled software and cybersecurity across US and international markets.

You will partner with Product, Engineering, Clinical, Quality, and Legal to shape strategy early, translate regulatory changes into actionable guidance, and build scalable governance for ongoing AI/ML product changes.

Qualifications

• 12+ years in Regulatory Affairs with depth in digital health and AI/ML.
• Direct experience engaging FDA and international regulators on software/AI/ML products.
• Knowledge of global regulatory frameworks for AI/ML, software lifecycle, risk management, quality systems, and cybersecurity.

Responsibilities

• Own global regulatory strategy for software and AI/ML 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 regulatory requirements and translate into business actions.
• Build scalable regulatory governance for AI/ML product changes and cybersecurity.
• Identify regulatory risks early and guide thoughtful decisions.
• Monitor global developments to position the business for upcoming changes.

Skills

Regulatory Affairs

AI/ML regulatory

FDA experience

Software lifecycle

Cybersecurity standards

Risk management

Stakeholder management

Education

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

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

Job description

Sr Manager, Global Regulatory Affairs (AI/ML)

Location
US Remote

Employment Type
Full time

Location Type
Remote

Department
POLICY

Compensation
$170K – $200K

Outlined above is a reasonable estimate of H&H’s compensation range for this role for US-based candidates. If you're based outside of the US, your recruiter will be able to provide you with an estimated salary range for your location.

The actual amount will take into account a range of factors that are considered in making compensation decisions, including but not limited to skill sets, experience and training, licensure and certifications, and location. H&H also offers a comprehensive Total Rewards package that may include an equity grant.

Consult with your Recruiter during any potential screening to determine a more targeted range based on location and job-related factors.

Overview

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.

You Will

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.

• 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

• 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