Global Regulatory Lead for AI-Driven Medical Software

Philips; Best; Hybrid; EUR 78,000 - 130,000; Full time

Job summary

Philips in the Netherlands seeks a Clinical Informatics Regulatory Lead to steer global regulatory strategy for AI-enabled healthcare software and clinical informatics solutions. You will collaborate across R&D, Quality, Clinical, Product Management, Cybersecurity, and Commercial teams to enable market access and lifecycle compliance.

You will influence regulatory risk, timelines, and business decisions, lead submissions to FDA, EU authorities, and notified bodies, and build a high-performing

Qualifications

• 8+ years of Regulatory Affairs experience with significant experience in medical devices and/or IVDs.
• Experience with SaMD, AI/ML-enabled products, cloud-connected solutions, cybersecurity, and interoperability is mandatory.
• Strong knowledge of FDA, EU MDR/IVDR, ISO 13485, ISO 14971, MDSAP, and global regulatory frameworks.

Responsibilities

• Lead global Regulatory Affairs strategy and execution across the Clinical Informatics portfolio.
• Drive regulatory pathways, submissions, registrations, and market access activities worldwide.
• Partner with R&D, Quality, Clinical, Product Management, Cybersecurity, and Commercial teams on new products, software releases, AI/ML capabilities, and market expansions.
• Advise senior leaders on regulatory risk, timelines, and business decisions.
• Represent the company with FDA, notified bodies, competent authorities, and regulators globally.
• Build and develop a high-performing Regulatory Affairs organization.

Skills

Regulatory strategy

Global leadership

FDA knowledge

EU MDR/IVDR

ISO 13485

MDSAP

SaMD/AI-ML

Cybersecurity

Interoperability

Education

Bachelor's or Master's degree in Biomedical Engineering / Life Sciences / Law

Job description

Philips in the Netherlands seeks a Clinical Informatics Regulatory Lead to steer global regulatory strategy for AI-enabled healthcare software and clinical informatics solutions. You will collaborate across R&D, Quality, Clinical, Product Management, Cybersecurity, and Commercial teams to enable market access and lifecycle compliance.

You will influence regulatory risk, timelines, and business decisions, lead submissions to FDA, EU authorities, and notified bodies, and build a high-performing