AI & Digital Health Regulatory Strategy Lead, Americas

563d Siemens Medical Solutions USA, Inc.; Washington (Washington County); On-site; USD 178,000 - 244,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid time off

Job summary

Siemens Healthineers is seeking an AI/Digital Health Regulatory Strategy Director for the Americas to lead regulatory strategy development across our product portfolio. You will shape approaches that enable timely, compliant, and impactful AI-enabled healthcare technologies while interfacing with FDA and other authorities.

You will partner with Regulatory, QA, Data & AI, R&D, and business units to define lifecycle strategies, governance, and evidence plans, ensuring alignment with privacy,

Qualifications

• Deep expertise in regulatory strategy, quality, or compliance for AI-enabled medical devices or digital health.
• Strong knowledge of U.S. FDA regulatory landscape and evolving global AI/digital health frameworks.
• Proven track record of developing and implementing AI/digital health regulatory strategies.
• Experience with regulatory authorities and engagement with industry standards bodies.

Responsibilities

• Define and drive AI and digital health regulatory strategy for the Americas.
• Provide strategic direction across the organization to enable AI regulatory approaches.
• Influence AI regulatory frameworks in the Americas and globally, incl. FDA engagement.
• Lead scalable AI-specific total product lifecycle regulatory strategies and guidance.
• Embed regulatory-by-design into AI product development and cross-functional collaboration.
• Translate evolving regulatory trends into actionable guidance for development and go-to-market.
• Ensure alignment with data governance, cybersecurity, privacy, and quality standards.
• Provide regulatory submissions guidance and interactions with FDA and others.

Skills

Regulatory strategy

Quality/compliance

AI/digital health

FDA knowledge

Education

Bachelor’s degree in life sciences, engineering, or related discipline

Job description

Siemens Healthineers is seeking an AI/Digital Health Regulatory Strategy Director for the Americas to lead regulatory strategy development across our product portfolio. You will shape approaches that enable timely, compliant, and impactful AI-enabled healthcare technologies while interfacing with FDA and other authorities.

You will partner with Regulatory, QA, Data & AI, R&D, and business units to define lifecycle strategies, governance, and evidence plans, ensuring alignment with privacy,