Director, AI & Digital Health Regulatory Strategy – Americas

Regulatory Jobs; Pennsylvania; 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

Long‑term and short‑term disability

Paid parking/public transportation

Paid time off

Paid sick time

Job summary

Siemens Healthineers is seeking an AI/Digital Health Regulatory Strategy Director for the Americas. You will shape regulatory approaches across the portfolio to enable timely, compliant AI-enabled healthcare products.

This role requires deep regulatory expertise, global ambition, and collaboration with regulators and cross-functional teams. You will drive scalable lifecycle regulatory strategies, embed regulatory-by-design, and ensure alignment with data governance and cybersecurity standards

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• 10+ years in regulatory affairs, quality, or compliance for AI/digital health devices.
• Experience in MedTech or tech companies with FDA knowledge preferred.
• Track record of developing and implementing AI/digital health regulatory strategies.
• Knowledge of quality systems, lifecycle processes, and AI regulatory standards.
• Ability to influence policy and engage with authorities and standards bodies.
• Strong communication with senior leaders and cross-functional teams.

Responsibilities

• Define and drive the AI and digital health regulatory strategy for the Americas.
• Provide strategic direction to teams across the organization.
• Influence AI regulatory frameworks in the Americas and globally, especially the US.
• Lead scalable, AI-specific total product lifecycle regulatory strategies and guidance.
• Embed regulatory-by-design principles into AI product development; collaborate across functions.
• Translate evolving requirements into actionable guidance for product development and go-to-market.
• Guide regulatory submissions and interactions with the FDA and other authorities.
• Align AI regulatory strategies with data governance, cybersecurity, privacy, and quality standards.

Skills

Regulatory strategy

Quality & compliance

Stakeholder communication

Regulatory submissions

AI regulatory concepts

Education

Bachelor’s degree in life sciences or engineering

Job description

Siemens Healthineers is seeking an AI/Digital Health Regulatory Strategy Director for the Americas. You will shape regulatory approaches across the portfolio to enable timely, compliant AI-enabled healthcare products.

This role requires deep regulatory expertise, global ambition, and collaboration with regulators and cross-functional teams. You will drive scalable lifecycle regulatory strategies, embed regulatory-by-design, and ensure alignment with data governance and cybersecurity standards