Senior Manager, Global Regulatory Affairs – AI/ML

This is a fully remote position, open to applicants in United States.

📋 Description

• Take charge of the global regulatory strategy for software and AI/ML-enabled products across both US and international markets.

• Create practical regulatory pathways that balance patient safety, product integrity, and business risks.

• Act as a regulatory collaborator with Product, Engineering, Clinical, Quality, and Legal teams.

• Provide guidance on emerging requirements related to AI/ML, digital health, and cybersecurity.

• Interpret regulatory changes and articulate their implications along with business recommendations.

• Establish regulatory and governance frameworks for modifications to AI/ML products, algorithm monitoring, software lifecycle requirements, and cybersecurity measures.

• Proactively identify regulatory risks and opportunities.

• Keep track of global regulatory developments and advocate for policies that support future offerings.

• Simplify complex regulatory requirements to make them understandable and actionable throughout the organization.

⛳️ Requirements

• At least 12 years of experience in Regulatory Affairs with substantial expertise in digital health and AI/ML.

• Proven experience in engaging with the FDA and international regulatory bodies on complex software and AI/ML products.

• Extensive knowledge of global regulatory frameworks and standards pertaining to AI/ML, software lifecycle, risk management, quality systems, and cybersecurity.

• Ability to assess risk, make informed decisions with incomplete information, and translate evolving requirements into clear and practical business recommendations.

• Proven ability to influence stakeholders across Product, Engineering, Clinical, Quality, Legal, and executive teams.

• Strong sense of ownership with the ability to navigate between strategic planning and hands-on execution in a dynamic environment.

• A Bachelor’s or Master’s degree in Biomedical Engineering, Computer Science, Data Science, Software Engineering, or a related field is required.

• Must be legally authorized to work in the U.S. without restrictions for any employer.

• Must not require immigration sponsorship by Hims & Hers to work in the U.S.

🏝️ Benefits

• Competitive salary and equity compensation for full-time positions.

• Unlimited paid time off (PTO).

• Company holidays.

• Quarterly mental health days.

• Comprehensive medical, dental, and vision benefits.

• Parental leave.

• Employee Stock Purchase Program (ESPP).

• 401k benefits with an employer matching contribution.

• Offsite team retreats.

• Flexible and remote work options.