Sr Manager, Global Regulatory Affairs (AI/ML)

hims & hers
United States
Workplace: RemoteFull timeUSD 170,000 - 200,000 annuallyFunction: Quality & Regulatory (Non-Software)Experience: 12+ yearsEducation: bachelorsSkills: ["Judgment","Risk assessment","Stakeholder influence","Ownership","Clarifying complex concepts"]

Own global regulatory strategy for software, AI/ML-enabled products, and cybersecurity requirements across US and international markets. Partner with Product, Engineering, Clinical, Quality, and Legal to shape strategy early, identify regulatory risks, and translate emerging AI/ML, digital health, and cybersecurity changes into practical recommendations. Build scalable regulatory frameworks for AI/ML governance, monitoring, and software lifecycle requirements while proactively tracking global developments to support responsible, fast-moving innovation.

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FursaFursa
hims & hers
hims & hers
2 days ago

Sr Manager, Global Regulatory Affairs (AI/ML)

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Source: Company careers pageValidated by: Fursa AI
Last checked: 14 hours agoStatus: Live

Job Summary

Own global regulatory strategy for software, AI/ML-enabled products, and cybersecurity requirements across US and international markets. Partner with Product, Engineering, Clinical, Quality, and Legal to shape strategy early, identify regulatory risks, and translate emerging AI/ML, digital health, and cybersecurity changes into practical recommendations. Build scalable regulatory frameworks for AI/ML governance, monitoring, and software lifecycle requirements while proactively tracking global developments to support responsible, fast-moving innovation.
Location: United States
Workplace: Remote
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Sr. Manager level

Key Responsibilities

  • •Own global regulatory strategy for software and AI/ML-enabled products across US and international markets, balancing patient, product, and business risk.
  • •Serve as a trusted regulatory partner to Product, Engineering, Clinical, Quality, and Legal to shape strategy early and provide clear, actionable viewpoints.
  • •Advise on emerging AI/ML, digital health, and cybersecurity requirements, translating regulatory changes into implications and recommendations.
  • •Build scalable regulatory and governance frameworks for AI/ML product changes, ongoing algorithm monitoring, software lifecycle requirements, and cybersecurity.
  • •Identify regulatory risks and opportunities early, proactively monitor global regulatory developments, and position the business for upcoming changes.

Pay and Benefits

Salary: USD 170,000 - 200,000 annually
Perks:Paid LeaveHealth InsuranceDentalVisionParental Leave401kEquity

Key Requirements

  • •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 for AI/ML, software lifecycle, risk management, quality systems, and cybersecurity.
  • •Ability to evaluate risk with imperfect information and translate evolving requirements into clear business recommendations.
  • •BSc or MSc in Biomedical Engineering, Computer Science, Data Science, Software Engineering, or related field required; advanced degree (MS, PhD, JD) or RAC valued.
Experience:12+ yearsDigital healthAI/MLRegulatory affairsSoftwareCybersecurity
Education:Bachelor's in Biomedical Engineering, Computer Science, Data Science, Software Engineering, or a related field
Skills:JudgmentRisk assessmentStakeholder influenceOwnershipClarifying complex concepts
Certifications:RAC
Tech Stack:AI/MLSoftwareCybersecurity

Company Brief

hims & hers
A telehealth and consumer wellness platform offering personalized care and products across sexual health, hair, mental health, dermatology, weight loss and primary care via digital consultations, prescriptions, and fulfillment.
Industry: HealthTech
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: San Francisco, United States
Founded: 2017
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Glassdoor: 2.9
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