AI/ Digital Health Regulatory Strategy Director, Americas

Siemens Healthineers•WAS PA, PA

2d•$177,780 - $244,453

About The Position

The AI/ Digital Health Regulatory Strategy Director, Americas, will lead the development and implementation of AI and digital health medical-device regulatory strategy across Siemens Healthineers’ Americas product portfolio. The role shapes regulatory approaches that support timely delivery of novel, compliant, and impactful AI-enabled healthcare products and services, and contributes to the evolving regulatory landscape for AI and digital health. The Director will define and drive regional strategy in alignment with patient and customer needs, business priorities, and jurisdictional requirements; provide strategic direction to teams developing innovative AI products; and influence regulatory frameworks through engagement with authorities, standards organizations, and other external stakeholders. The role also leads scalable, AI-specific total product lifecycle strategies, frameworks, policies, and guidance; embeds regulatory-by-design principles; and translates regulatory and competitive developments into practical product-development and go-to-market guidance. Working across business lines and functions—including research and development, Data & AI, Quality, and Regulatory—the Director will guide regulatory submissions and authority interactions, including with the FDA, and define suitable evidentiary standards for AI devices and digital health products. The position ensures alignment with data governance, responsible AI, clinical excellence, cybersecurity, data privacy, and quality standards, while encouraging shared learning and regulatory best practices across the organization.

Requirements

Bachelor’s degree in life sciences, engineering, or a related discipline.
10 or more years of professional experience in regulatory affairs, quality, or compliance for AI/digital health medical devices.
Experience within MedTech or technology companies and strong knowledge of regulatory expectations for AI and digital health.
Track record of developing and implementing AI or digital health product regulatory strategies, 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.
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 to engage effectively with regulatory authorities, senior leaders, technical experts, and cross-functional stakeholders.
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 and strong understanding of evolving global AI and digital health regulatory frameworks.
Experience navigating emerging regulatory areas with limited precedent and translating evolving requirements into practical strategies for product teams.
Ability to influence regulatory policy, frameworks, or standards through engagement with authorities, industry organizations, or standards bodies.
Ability to partner with senior business, technical, clinical, quality, and regulatory stakeholders in a complex global organization.
Structured, risk-oriented thinking, strong attention to detail, and ability to provide clear strategic direction in rapidly evolving technical and regulatory environments.
Passion for responsible innovation and advancing AI-enabled healthcare technologies.

Nice To Haves

Advanced degree preferred.
Experience within regulatory authorities, such as the FDA, preferred.

Responsibilities

Define and drive AI and digital health regulatory strategy for the Americas, aligned with patient and customer needs, business priorities, and jurisdictional requirements.
Provide strategic direction and enablement to organizational teams advancing innovative regulatory approaches for new and precedent-setting AI products and solutions.
Influence AI regulatory frameworks in the Americas and globally, particularly in the United States, through engagement with regulatory authorities, standards organizations, and 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 with business lines, research and development, Data & AI, Quality, Regulatory, and other functions.
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 guide regulatory submissions and interactions with the FDA and other authorities, including defining appropriate evidentiary standards for AI devices and other digital health products.
Ensure AI regulatory strategies align with data governance, responsible AI, clinical excellence, cybersecurity, data privacy, and quality standards.
Promote shared learning and regulatory best practices across the organization.