Global Regulatory Affairs Lead, AI-Enabled Clinical Informatics

Philips

Best

Hybrid

EUR 78,000 - 130,000

Full time

3 days ago

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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.