AI & Digital Health Regulatory Strategy Director Americas

Siemens Healthineers AG; Washington (District of Columbia); Sur place; USD 178 000 - 244 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Long-term and short-term disability

Paid parking/public transportation

Paid time off

Paid sick and safe time

Résumé du poste

Siemens Healthineers is seeking an AI/Digital Health Regulatory Strategy Director for the Americas. You will shape regulatory paths for AI-enabled medical devices across the portfolio, engaging with FDA and other authorities to enable timely, compliant product delivery.

You will guide teams, embed regulatory-by-design, and translate evolving requirements into practical strategies for product development, data governance, privacy, and quality standards in a global context.

Qualifications

• 10+ years of professional experience in regulatory affairs, quality, compliance for AI/digital health medical devices.
• Deep expertise in regulatory strategy for AI-enabled medical devices.
• Expert knowledge of the U.S. FDA regulatory landscape and evolving global AI/digital health frameworks.
• Experience developing regulatory strategies including evidence generation, submissions, and lifecycle considerations.
• Ability to influence regulatory policy and engage regulators and senior stakeholders globally.
• Proven track record across AI/digital health regulatory policy and standards.

Responsabilités

• Define and drive the AI and digital health regulatory strategy for the Americas.
• Provide strategic direction to teams across the organization for innovative AI products.
• Influence AI regulatory frameworks in the Americas and globally, especially the US.
• Define and lead scalable, AI-specific total product lifecycle regulatory strategies.
• Embed regulatory-by-design into AI product development and cross-functional collaboration.
• Assess evolving requirements and translate them into actionable guidance for product teams.
• Partner with Regulatory on submissions and FDA/other authorities engagements.
• Ensure alignment with data governance, privacy, cybersecurity, and quality standards.

Connaissances

Regulatory strategy

Quality/compliance

AI regulatory knowledge

FDA/regulatory affairs

Stakeholder management

Regulatory submissions

Lifecycle management

Regulatory policy influence

Formation

Bachelor's degree in life sciences/engineering

Advanced degree preferred

Description du poste

Siemens Healthineers is seeking an AI/Digital Health Regulatory Strategy Director for the Americas. You will shape regulatory paths for AI-enabled medical devices across the portfolio, engaging with FDA and other authorities to enable timely, compliant product delivery.

You will guide teams, embed regulatory-by-design, and translate evolving requirements into practical strategies for product development, data governance, privacy, and quality standards in a global context.