SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
Hims & Hers, a leading digital health platform and NYSE-traded public company, is seeking a Senior Manager of Global Regulatory Affairs (AI/ML) to lead regulatory strategy for software and AI/ML-enabled healthcare products across US and international markets.
In this role, you will own the global regulatory strategy for software, AI/ML-enabled products, and cybersecurity requirements. You will serve as a trusted regulatory partner to Product, Engineering, Clinical, Quality, and Legal teams, helping them understand regulatory possibilities, identify risks, and create practical pathways to bring new capabilities to market responsibly. You will work at the intersection of rapidly evolving regulation and technology, translating complex regulatory requirements into clear, actionable business recommendations.
Key responsibilities include:
- Developing and executing global regulatory strategy for software and AI/ML products across US and international markets, balancing speed, innovation, and risk
- Advising cross-functional teams on emerging AI/ML, digital health, and cybersecurity regulatory requirements
- Building scalable regulatory and governance frameworks for AI/ML product changes, algorithm monitoring, software lifecycle management, and cybersecurity
- Identifying regulatory risks and opportunities early to inform product and business strategy
- Proactively monitoring global regulatory developments and championing policies that enable future offerings
- Engaging FDA and international regulatory authorities on complex software and AI/ML submissions
- Making technical regulatory concepts accessible and actionable across the organization
This is a highly cross-functional role requiring someone who combines deep regulatory expertise with strong business judgment, comfort with ambiguity, and the ability to move fluidly between strategy and hands-on execution.
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 related field (required); advanced degree (MS, PhD, JD) or RAC certification valued
