Director of Regulatory Affairs - Informatics
P
Philips
📍 Haifa, Israel, Israel
Job 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:**
+ **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 compliant.
+ **Cross-Functional Collaboration:** Partner with R&D, Quality, Clinical, and Product teams to ensure regulatory requirements are inte...
**Your role:**
+ **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 compliant.
+ **Cross-Functional Collaboration:** Partner with R&D, Quality, Clinical, and Product teams to ensure regulatory requirements are inte...