Director of Regulatory Affairs - Informatics
P
Philips
📍 Haifa, Haifa, Israel
Job Description
JOB DESCRIPTION Regulatory Leadership: Develop and implement global regulatory strategies for software-enabled medical devices (including SaMD, non-device health IT) across the product lifecycle. Compliance & Submissions: Oversee the preparation and submission of regulatory filings (e.g., FDA pre-submissions, IDE, 510(k), EU MDR Technical Files/Design Dossiers) for US, EU, and other markets. Support in post market activities to ensure devices remain com...
Job Title
Director of Regulatory Affairs - InformaticsJob Description
The Director of Regulatory Affairs Informatics leads regulatory strategy and execution for software-enabled solutions, both device and non-device across areas like PACS, radiology, cardiology, pathology, urology, and virtual care. The role ensures compliance with FDA, EU MDR, and global regulations, focusing on cloud, AI transformation, and third-party software integration.
Your role: