Sr Manager, Global Regulatory Affairs (AI/ML)

For our client, we are seeking a Sr Manager, Global Regulatory Affairs (AI/ML) to join the team of a leader in the Healthcare space. This role will shape global regulatory strategy for software and AI/ML products across U.S. and international markets. The person in this position will partner closely with Product, Engineering, Clinical, Quality, and Legal teams to help guide compliant innovation and informed business decisions. It is an important opportunity to build scalable regulatory frameworks, assess emerging risks, and translate complex requirements into practical actions for a fast-moving digital health environment. Location: Remote - US based candidates only, no visa sponsorship available Compensation: $150,000 – $180,000 annually Responsibilities Own global regulatory strategy for software and AI/ML products across U.S. and international markets Serve as a regulatory partner for Product, Engineering, Clinical, Quality, and Legal teams Advise on emerging AI/ML, digital health, and cybersecurity regulations Build scalable regulatory frameworks for product changes and ongoing monitoring Identify regulatory risks and opportunities early for informed decision-making Monitor global regulatory developments to guide business strategy Translate complex regulatory requirements into actionable insights for teams Qualifications 12+ years of experience in Regulatory Affairs, especially in digital health and AI/ML Direct experience with FDA and international regulatory authorities In-depth knowledge of global regulatory frameworks for AI/ML and software Ability to evaluate risks and make decisions with limited information Strong influencing skills across cross-functional teams, including stakeholders Proven ability to shift between strategy and detailed execution in a fast-paced environment BSc or MSc in Biomedical Engineering, Computer Science, or a related field; advanced degrees valued Benefits Competitive salary and equity for full-time roles Unlimited PTO, company holidays, and quarterly mental health days Comprehensive health benefits including medical, dental, and vision Employee stock purchase program 401(k) with employer matching Offsite team retreats Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.