Clinical Evaluation & Compliance Leader, Enterprise Informatics

Job Title Clinical Evaluation & Compliance Leader, Enterprise Informatics Job Description The Clinical Evaluation and Compliance Leader leads the clinical evaluation, post-market clinical follow-up, and evidence compliance strategy for the Enterprise Informatics portfolio. The role ensures that clinical evaluation documentation and related governance are scientifically robust, inspection-ready, and aligned with regulatory submissions, product claims, and post-market lifecycle needs. Working across Quality & Regulatory, R&D, Product Management, Medical Affairs, and the business, the leader translates clinical and regulatory requirements into practical, compliant evidence plans. Your role

• Lead the Enterprise Informatics clinical evaluation and compliance strategy across the product lifecycle, from early development through launch, market expansion, and post-market surveillance.
• Set clear goals, operating rhythms, performance expectations, and KPIs for the Clinical Evaluation and Compliance team; recruit, develop, and retain high-performing talent while fostering a collaborative, accountable work environment.
• Own the development, maintenance, and quality of Clinical Evaluation Plans and Reports, literature reviews, evidence maps, state-of-the-art assessments, and Post-Market Clinical Follow-up Plans and Reports, as applicable.
• Critically evaluate pre-clinical, clinical, usability, performance, and real-world data to support conformity with applicable General Safety and Performance Requirements, product claims, benefit-risk assessments, and design-validation conclusions.
• Establish and continuously improve clinical evaluation procedures, templates, writing standards, tools, and governance; ensure early adoption of evolving external standards, regulations, and Philips requirements.
• Partner with Quality & Regulatory and Risk Management to integrate clinical evidence into risk management, design control, change assessment, audits, corrective actions, and regulatory submission strategies.
• Provide quality oversight of essential study, clinical evaluation, and post-market documents, ensuring traceability, consistency, accuracy, completeness, and readiness for internal audit, notified-body review, monitor emerging clinical, regulatory, standards, and technology developments relevant to Enterprise Informatics, including cloud software, interoperability, and AI-enabled applications; identify implications, gaps, and improvement opportunities. You're the right fit if:
• You have a minimum of 10+ years’ progressive experience in Clinical Affairs, Clinical Evaluation, Medical writing, Clinical Development, Regulatory Affairs, and/or Evidence Generation within the medical device industry. Experience with software as a medical device (SaMD), digital health, imaging informatics, or related preferred. Experience in enterprise imaging, advanced visualization,, radiology or cardiology informatics, structure reporting, interoperability, cloud software or AI-enabled clinical applications strongly preferred.
• You have a master’s degree in a related field required, PhD/MD preferred.
• Your skills include demonstrated experience authoring, reviewing, developing or leading Clinical Evaluations Plans and Reports, and post market clinical follow-up documentation for medical devices and/or software products.
• Strong knowledge of clinical evaluation methodology, literature review, evidence appraisal, and applicable global requirements, including

EU Mdr

clinical evaluation expectations, GCP, ISO 14155, and relevant FDA medical-device requirements are a must.

• Strong experience partnering with cross functional stakeholders to support design controls, regulatory submissions, audits, corrective actions, and product lifecycle decisions required.
• Ability to successfully perform the physical, cognitive, and environments requirements of the position with or without reasonable accommodations. Compensation: Doing meaningful work should come with fair, transparent rewards. The base salary range for this role is €78,187–€130,312. How we work together: We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an Office role . About Philips: We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of your life to help improve the lives of others.
• Learn more about our business .
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture. Additional Information:
• May travel up to 25% (Domestic & International)