AI/ Digital Health Regulatory Strategy Director, Americas

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. At Siemens Healthineers, we are committed to transforming healthcare through innovation and artificial intelligence. The role of AI/ Digital Health Regulatory Strategy Director, Americas will lead the development and implementation of our AI and digital health medical device regulatory strategy for the Americas across the Siemens Healthineers product portfolio. This leader will play a critical role in shaping regulatory approaches that enable the timely delivery of novel, compliant, and impactful AI-enabled healthcare products and services, while helping influence the evolving regulatory landscape for AI and digital health. This is a role well suited to an ambitious professional looking for the next step in their career. In this role, you will be responsible for: You will 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. You will provide strategic direction and enablement to teams across the organization, advancing innovative regulatory approaches for new and precedent-setting AI products and solutions. You will 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. You will define and lead scalable, AI-specific total product lifecycle regulatory strategies, frameworks, policies, and guidance. You will 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. You will 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. You will 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. You will 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. This position may suit you best if you are familiar with what is below and would like to develop your career with Healthineers: You have deep expertise in regulatory strategy, quality, or compliance for AI-enabled medical devices or other digital health technologies. You possess 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. You have 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. You are experienced in navigating emerging regulatory areas where established precedents may be limited and can translate evolving requirements into practical strategies for product teams. You have demonstrated the ability to influence regulatory policy, frameworks, or standards through engagement with regulatory authorities, industry organizations, or standards bodies. You are skilled at partnering with senior business, technical, clinical, quality, and regulatory stakeholders across a complex, global organization. You bring structured, risk-oriented thinking, strong attention to detail, and the ability to provide clear strategic direction in rapidly evolving technical and regulatory environments. You are passionate about enabling responsible innovation and advancing the development and adoption of AI-enabled healthcare technologies. Required skills to have for the success of this role: 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. Demonstr #J-18808-Ljbffr Siemens Healthineers