Director of Regulatory AI & Digital Innovation

This Director of Regulatory AI & Digital Innovation role at Philips aims to transform IGTS Regulatory Affairs into an an AI-powered, digitally enabled function. The role involves shaping regulatory frameworks for AI and software, strengthening readiness for NMPA, EU MDR, FDA, upskilling teams in AI and digital tools, driving cross-functional governance, and leading RA AI strategy to accelerate regulatory execution and increase global submission efficiency.

Must Have

• Bachelor's / Master's Degree in (Biomedical) Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent
• Minimum 8 years of experience in Regulatory Affairs, Quality Compliance, Product Development in Medical Devices Industry
• Well versed in AI regulations (NMPA, EU MDR, FDA) and their application to Medical devices

Role PurposeTransform IGTS Regulatory Affairs into an AI-powered, digitally enabled function that accelerates speed-to-market, strengthens compliance, and supports innovation in AI, software, and regionally complex markets.

Your role:

Support Regional Regulatory Strategy

• Shape regulatory frameworks for AI and continuous software delivery; engage early in innovation.
• Strengthen readiness for NMPA, EU MDR, FDA; ensure digital tooling supports regionalization and dual-track pathways.

Build Future-Ready RA Skills

• Upskill teams in AI, software regulation, and digital tools; reduce single points of failure; support RA workforce planning.

Drive Cross-Functional Governance

• Align with Product Management, Portfolio, Advanced Development & Customer Success to embed regulatory strategy across lifecycle.

Lead RA AI Strategy & Tools

• Deploy structured content authoring, dossier automation, regulatory intelligence curation, and automated QC.

Accelerate Regulatory Execution

• Reduce manual work, eliminate backlog, and increase global submission efficiency.

You're the right fit if you have:

• Bachelor's / Master's Degree in (Biomedical) Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent.
• Minimum 8 years of experience in areas such as Regulatory Affairs, Quality Compliance, Product Development in Medical Devices Industry or equivalent.
• Well versed in AI regulations(NMPA, EU MDR and/or FDA) and how to apply it to Medical devices Strategic and innovative thinker with a proven capacity to challenge conventions and develop breakthrough solutions.

You are a part of

The global Philips regulatory organization of Image Guided Therapy Systems (IGT-S) and will be reporting to the Regulatory leader for IGT-S in the Netherlands. The team you will be working in, is a high-performance, culturally diverse, and very dynamic team. It consists of >50 people working in the areas, divided over China , India and the Netherlands.

How we work together

We believe that we are better together than apart. For this role, this means working in-person at least 3 days per week.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.

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