Description
As Hims & Hers continues to expand its use of software, AI, and machine learning across its healthcare platform, we are seeking a Senior Manager, Global Regulatory Affairs (AI/ML) to lead regulatory strategy for these rapidly evolving areas.
This role involves owning global regulatory strategy for software and AI/ML-enabled products, working closely with Product, Engineering, Clinical, Quality, and Legal teams to shape product strategy early, navigate complex regulatory questions, and create practical paths forward.
The ideal candidate has 12+ years of experience in Regulatory Affairs with a focus on digital health and AI/ML, direct experience engaging with the FDA and international regulatory authorities, and deep knowledge of global regulatory frameworks and standards governing AI/ML, software lifecycle, risk management, quality systems, and cybersecurity.
Key responsibilities include:
- Developing practical pathways for global regulatory strategy
- Serving as a trusted regulatory partner across teams
- Advising on emerging AI/ML, digital health, and cybersecurity requirements
- Building scalable regulatory and governance frameworks
- Identifying regulatory risks and opportunities early
- Proactively monitoring global regulatory developments
The compensation range for this role is $170K - $200K, with a comprehensive Total Rewards package that may include an equity grant.
Benefits include:
- Competitive salary & equity compensation
- Unlimited PTO, company holidays, and quarterly mental health days
- Comprehensive health benefits
- Employee Stock Purchase Program (ESPP)
- 401k benefits with employer matching contribution
- Offsite team retreats