Director of Regulatory Affairs - Informatics

Philips(2 months ago)

HybridFull TimeDirector$192,566 - $255,660 (estimated)Regulatory Affairs

About this role

The Director of Regulatory Affairs - Informatics leads global regulatory strategy and execution for software-enabled and non-device healthcare solutions across domains such as PACS, radiology, cardiology, pathology, urology, and virtual care. The role focuses on ensuring compliance with FDA, EU MDR, and other international regulations while addressing cloud, AI transformation, and third-party software integration.

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Required Skills

Regulatory Strategy
FDA Submissions
EU MDR
SaMD
Cloud Computing
AI/ML
Software Integration
Vendor Management
QMS
Cybersecurity

+4 more

Qualifications

Master's Degree in Informatics, Engineering, Life Sciences or Related

About Philips

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