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.

• 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.

Who we are : We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Siemens Healthineers businesses, please visit our company page here.

The base pay range for this position is:

$177,780 - $244,453

Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.

Equal Employment Opportunity Statement: Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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