Clinical Informatics Regulatory Lead

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

Clinical Informatics Regulatory Lead: In this role you will lead global regulatory strategy for a portfolio of AI-enabled healthcare software, Digital & Computational Pathology, Disease Management Systems, and clinical informatics solutions.

As a member of the Clinical Informatics leadership team, you will drive regulatory strategy, market access, lifecycle compliance, and regulatory excellence across global markets while enabling innovation in software, cloud-connected, and AI-powered technologies.

• Full time.

Your role:

• 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.

You're the right fit if you have:

• Bachelor's / Master's Degree in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent.
• Strong knowledge of FDA, EU MDR/IVDR, ISO 13485, ISO 14971, MDSAP, and global regulatory frameworks.
• 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.
• Proven leadership of global regulatory strategies and complex product portfolios.
• Experience in clinical informatics, digital pathology, radiology, oncology, urology, or diagnostic imaging preferred.
• Strong people leadership, executive presence, and stakeholder influence skills.

Compensation & benefits for Netherlands

Doing meaningful work should come with fair, transparent rewards. The base salary range for this role is EUR 78,187.00 - EUR 130,312.00 gross per year. We determine pay within the range using objective factors, like the skills the role requires, your relevant experience and the responsibility you'll have in this role, alongside internal equity and local market considerations.

This role is eligible for 3% short term incentive with your rewards linked to both individual performance and company results. Benefits include hybrid working, paid time-off, health and wellbeing benefits, learning and development opportunities.

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.