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Senior Regulatory Affairs Specialist

Philips • Orange, OH, US • published 2026-10-28 03:17:06.907442

Description

### **Job Title** Senior Regulatory Affairs Specialist ### **Job Description** The Senior Regulatory Affairs Specialist is responsible for driving key regulatory initiatives contributing to the development and implementation of regulatory strategies, ensuring Philips Computed Tomography (CT)/Advanced Molecular Imaging (AMI) products are safe, effective, and compliant with global regulatory requirements **Your role:** * Serve as a Regulatory expert for 510(k) and CE Mark/EU MDR compliance, including interpretation and application of regulations, guidance, and standards across integrated hardware systems and complex device portfolios. * Lead and influence global regulatory strategies to support market expansion and lifecycle management, with emphasis on system\-level hardware integration considerations for US, EU, Japan, Canada, and other international markets as required. * Provide regulatory leadership and strategic guidance to internal stakeholders (R\&D, Quality, Clinical, Marketing, Manufacturing, Supply Chain, etc.) to ensure regulatory requirements are embedded into hardware system architecture, design inputs, verification, and validation activities. * Drive preparation, revie...

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