Senior Manager, Global Regulatory Affairs – AI/ML

🕒 September 25

🇺🇸 United States – Remote

💵 $170k - $200k / year

⏰ Full Time

🟠 Senior

🤖 Artificial Intelligence

👻 Ghost score 0%

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hims & hers

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2017

🏥 Healthcare

💼 Consulting

📣 Marketing

Healthcare • Consulting • Marketing

Hims & Hers is an online platform with over 1 million subscribers that connects patients to licensed healthcare professionals across all 50 states in the U. S. The service offers comprehensive support for sexual health, weight loss, hair regrowth, mental health, and skincare through a 100% online process. Clients can receive personalized treatment plans which may include prescription medications, and benefit from free and discreet shipping. Hims & Hers prides itself on providing accessible and affordable healthcare without the need for insurance, offering transparent pricing and support from licensed providers. It aims to empower individuals by making healthcare and treatment conveniently available on their own terms, including mental health support, which includes treatments for anxiety and depression.

📋 Description

• Own global regulatory strategy for software and AI/ML-enabled products across US and international markets • Develop practical regulatory pathways balancing patient, product, and business risk • Serve as a regulatory partner to Product, Engineering, Clinical, Quality, and Legal teams • Advise on emerging AI/ML, digital health, and cybersecurity requirements • Translate regulatory changes into clear implications and business recommendations • Build regulatory and governance frameworks for AI/ML product changes, algorithm monitoring, software lifecycle requirements, and cybersecurity • Identify regulatory risks and opportunities early • Monitor global regulatory developments and champion policies supporting future offerings • Make complex regulatory requirements understandable and actionable across the organization

🎯 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 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 • 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 • Legally authorized to work in the U.S. without restriction for any employer • Must not require immigration sponsorship by Hims & Hers to work in the U.S.

🏖️ Benefits

• Competitive salary & equity compensation for full-time roles • Unlimited PTO • Company holidays • Quarterly mental health days • Comprehensive medical, dental & vision benefits • Parental leave • Employee Stock Purchase Program (ESPP) • 401k benefits with employer matching contribution • Offsite team retreats • Flexible/remote work approach