Senior Regulatory Affairs Specialist

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, review, and maintenance of EU MDR Technical Documentation, including oversight of conformity assessment activities and interactions with Notified Bodies. #J-18808-Ljbffr Philips