AI/ Digital Health Regulatory Strategy Director, Americas

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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 famili...