AI/ Digital Health Regulatory Strategy Director, Americas

Responsibilities

• Define and drive the AI and digital health regulatory strategy for the Americas, aligning regulatory approaches with patient and customer needs, business priorities, and evolving jurisdictional requirements.
• Provide strategic direction and enablement to teams across the organization, advancing innovative regulatory approaches for new and precedent-setting AI products and solutions.
• Influence AI regulatory frameworks in the Americas and globally, with a particular focus on the United States, through engagement with regulatory authorities, standards organizations, and other external stakeholders.
• Define and lead scalable, AI-specific total product lifecycle regulatory strategies, frameworks, policies, and guidance.
• Embed regulatory-by-design principles into AI product development and partner across business lines, research and development, Data & AI, Quality, Regulatory, and other functions to enable consistent and effective regulatory practices.
• Assess the evolving regulatory and competitive landscape and translate emerging requirements and trends into actionable guidance for AI and digital health product development and go-to-market strategies.
• Partner with Regulatory teams to provide strategic guidance for regulatory submissions and interactions with the FDA and other regulatory authorities, including defining appropriate evidentiary standards for AI devices and other digital health products.
• Ensure alignment of AI regulatory strategies with data governance, responsible AI, clinical excellence, cybersecurity, data privacy, and quality standards while promoting shared learning and regulatory best practice across the organization.

Qualifications

• Deep expertise in regulatory strategy, quality, or compliance for AI-enabled medical devices or other digital health technologies.
• Expert knowledge of the U.S. FDA regulatory landscape and processes as well as a strong understanding of evolving global regulatory frameworks for AI and digital health.
• Successfully developed and implemented regulatory strategies for innovative AI or digital health products, including evidence generation, regulatory pathways and submissions, and post-market lifecycle considerations.
• Experienced in navigating emerging regulatory areas where established precedents may be limited and can translate evolving requirements into practical strategies for product teams.
• Demonstrated ability to influence regulatory policy, frameworks, or standards through engagement with regulatory authorities, industry organizations, or standards bodies.
• Skilled at partnering with senior business, technical, clinical, quality, and regulatory stakeholders across a complex, global organization.
• Structured, risk-oriented thinking, strong attention to detail, and the ability to provide clear strategic direction in rapidly evolving technical and regulatory environments.
• Passionate about enabling responsible innovation and advancing the development and adoption of AI-enabled healthcare technologies.

Required Skills

• Bachelor’s degree in life sciences, engineering, or a related discipline required; advanced degree preferred.
• 10+ years of professional experience in regulatory affairs, quality, compliance for AI/digital health medical devices.
• Demonstrated experience within MedTech or technology companies, with strong knowledge of regulatory expectations for AI and digital health required.
• Experience within regulatory authorities (such as the FDA) preferred.
• Proven track record of developing and implementing regulatory strategies for AI or digital health products, including regulatory policy, evidence generation, submissions, marketing authorization pathways, and total product lifecycle considerations.
• Strong knowledge of quality management systems, regulatory lifecycle processes, and emerging AI regulatory concepts and standards.
• Demonstrated ability to establish scalable regulatory approaches and drive consistent implementation of AI and digital health regulatory policy across a broad and diverse product portfolio.
• Strong credibility and communication skills with the ability to effectively engage regulatory authorities, senior leaders, technical experts, and cross-functional stakeholders.