Clinical Informatics Regulatory Lead

NL9A NL Best Industrial; Best; Hybrid; EUR 78,000 - 130,000; Full time

Benefits offered by this job

hybrid working

paid time-off

health and wellbeing benefits

learning and development opportunities

Job summary

Philips is seeking a Clinical Informatics Regulatory Lead to drive worldwide regulatory strategy for a portfolio including AI-enabled healthcare software and digital pathology. You will influence product lifecycles, ensure compliance, and partner with cross-functional teams across R&D, Quality, Clinical, and Cybersecurity to enable innovation.

The role requires leading regulatory submissions, risk assessments, and strategic decisions while collaborating with global regulators.

Qualifications

• 8+ years of Regulatory Affairs experience with medical devices and/or IVDs.
• Experience with SaMD, AI/ML-enabled products, cloud-connected solutions, cybersecurity.
• Proven leadership of global regulatory strategies across complex product portfolios.
• Strong knowledge of FDA, EU MDR/IVDR, ISO 13485, ISO 14971, MDSAP and global regulatory frameworks.
• Experience in clinical informatics, digital pathology, radiology, oncology, or diagnostic imaging preferred.

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 leadership

Global strategy

Stakeholder management

Clinical informatics

AI/ML in SaMD

Education

Biomedical Engineering

Business Administration

Health Sciences

Pharmaceutical

Law

Job description

Job Title: 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.

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.

Qualifications

• 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

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. We'll share the full approach with you during the interview process, so you can make a clear, informed decision.

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.

About Philips

Are you ready to do the work of your life to help the lives of others? Learn more about our business, discover our rich and exciting history and learn more about our purpose. Learn more about our culture of impact with care.

At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners.

Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success.

It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism.

To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

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