[All remote jobs](https://jobicy.com/jobs.md)[![hims & hers logo](https://jobicy.com/data/server-nyc0409/galaxy/mercury/2023/11/e7b9b920-221.jpeg)](https://jobicy.com/company/hims-hers.md)[hims & hers](https://jobicy.com/company/hims-hers.md) # Sr Manager, Global Regulatory Affairs (AI/ML) Review the role, location requirements, compensation details, and application process before deciding whether this opportunity fits your next career move. [Apply for this job](#job-application)[View company](https://jobicy.com/company/hims-hers.md)ShareRemote from[USA](https://jobicy.com/job-region/usa.md)SalaryUSD 170k–200k / yrDepartment[Legal & Compliance](https://jobicy.com/categories/legal.md)EmploymentFull TimeExperienceDirectorPublished29 Oct 2026Apply before28 Nov 2026Listing views59Application actions2Application toolkit ## Make your next move. Prepare your resume, explore your fit, and draft a cover letter for this opportunity. AI Summary ## The role, at a glance. This senior regulatory leadership role owns global regulatory strategy for software, AI/ML-enabled healthcare products, cybersecurity, and digital-health compliance. The manager will partner closely with Product, Engineering, Clinical, Quality, and Legal teams to assess risk and create practical pathways to market. The position requires direct experience with FDA and international regulators, plus deep knowledge of software lifecycle, quality-system, risk-management, and AI/ML frameworks. Success depends on translating emerging requirements into actionable guidance while balancing innovation, patient safety, business priorities, and regulatory risk. ## Role DNA A quick view of the complexity, pace, ownership and collaboration implied by the job description. ### Job Complexity 5/5EasyHard ### Pace & Pressure 5/5RelaxedFast-paced ### Autonomy Level 5/5GuidedFull ownership ### Communication Load 5/5IndependentCollaborative AI insightThe role requires 12+ years of specialized regulatory experience and accountable judgment in fast-changing, globally regulated AI/ML healthcare environments. It combines strategic ownership, regulator engagement, technical fluency, and executive-level cross-functional influence. ## Salary analysis Estimated compensation compared with the broader US market for similar roles. Estimated job median (per year)Market rate$185,000US market range (per year)$175k–$230k0$253.00k AI insightThe employer discloses a base compensation range of $170,000 to $200,000 USD per year, with a midpoint of $185,000. Estimated US annual market compensation for a senior global regulatory affairs leader specializing in digital health and AI/ML is approximately $175,000 to $230,000 USD; actual pay may vary by location, scope, credentials, and equity. ## Core skills Skills and capabilities most closely associated with this opportunity. [Regulatory Affairs](https://jobicy.com/jobs?search_keywords=Regulatory%20Affairs.md)[Digital Health Regulation](https://jobicy.com/jobs?search_keywords=Digital%20Health%20Regulation.md)[AI/ML Compliance](https://jobicy.com/jobs?search_keywords=AIML%20Compliance.md)[FDA Engagement](https://jobicy.com/jobs?search_keywords=FDA%20Engagement.md)[International Regulatory Strategy](https://jobicy.com/jobs?search_keywords=International%20Regulatory%20Strategy.md)[Software as a Medical Device](https://jobicy.com/jobs?search_keywords=Software%20as%20a%20Medical%20Device.md)[Cybersecurity Regulation](https://jobicy.com/jobs?search_keywords=Cybersecurity%20Regulation.md)[Quality Management Systems](https://jobicy.com/jobs?search_keywords=Quality%20Management%20Systems.md)[Risk Management](https://jobicy.com/jobs?search_keywords=Risk%20Management.md)[Software Lifecycle Management](https://jobicy.com/jobs?search_keywords=Software%20Lifecycle%20Management.md)[Regulatory Intelligence](https://jobicy.com/jobs?search_keywords=Regulatory%20Intelligence.md)[Cross-functional Leadership](https://jobicy.com/jobs?search_keywords=Cross-functional%20Leadership.md)[Clinical Compliance](https://jobicy.com/jobs?search_keywords=Clinical%20Compliance.md)[Stakeholder Management](https://jobicy.com/jobs?search_keywords=Stakeholder%20Management.md) Sample interview questionsHow would you develop a regulatory strategy for a new AI/ML-enabled healthcare product with an uncertain classification?I would begin by defining the intended use, clinical claims, user population, data flows, and level of automation. I would map these facts against FDA and relevant international frameworks, identify classification and evidence scenarios, and document key risks and assumptions. I would then present decision-ready options to cross-functional leaders, including timelines, validation needs, and mitigation plans. Describe how you would govern ongoing changes to a machine-learning algorithm after launch. I would establish a change-control framework that distinguishes predefined, validated changes from changes requiring further assessment or regulatory interaction. The framework would include model performance thresholds, bias and safety monitoring, data-drift controls, documentation requirements, review ownership, and escalation criteria. This allows teams to improve the product while maintaining traceability and patient-safety oversight. How do you explain a complex regulatory risk to product and engineering leaders? I focus on the business decision rather than reciting regulations. I describe the applicable requirement, the practical product impact, the likelihood and severity of the risk, and clear options with recommended next steps. This approach helps technical teams understand both the reason for a control and how to implement it efficiently. What is your approach to engaging the FDA or another regulatory authority on novel software or AI/ML questions? I prepare a focused engagement strategy with a clear regulatory question, concise product description, supporting evidence, and specific decisions needed from the authority. I align internal stakeholders beforehand so the company presents consistent positions and can respond credibly to follow-up questions. After the interaction, I translate feedback into owners, timelines, and documented product or regulatory actions. How would you balance speed to market with regulatory uncertainty for an innovative healthcare capability? I would identify the non-negotiable patient-safety and compliance requirements first, then create phased options that reduce uncertainty early through evidence generation, controlled launches, or scoped claims. I would make tradeoffs transparent, including what can proceed now, what requires additional validation, and what risks leadership is accepting. The goal is a practical path that enables progress without creating unmanaged regulatory exposure. Opportunity details ## About this role. 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](http://hims.com/about) and [hims.com/how-it-works](http://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](http://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 [accommodations@forhims.com](mailto:accommodations@forhims.com) 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](https://www.hims.com/global-candidate-privacy-statement). 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