The Regulatory Affairs Specialist I supports regulatory activities to help ensure Philips Image Guided Therapy Devices are safe, effective, and compliant with applicable global regulatory requirements. This role also provides an excellent opportunity to develop expertise in medical device regulations, including FDA regulations, EU MDR requirements, and international regulatory processes.

**Your role:**

+ Support preparation, review, and maintenance of regulatory documentation for medical device products.
+ Assist with regulatory submissions, registrations, renewals, and product change assessments under the guidance of senior regulatory professionals.
+ Contribute to the development and maintenance of Technical Documentation and Design History Files to support regulatory compliance.
+ Research and interpret regulatory requirements, standards, guidance documents, and industry best practices.
+ Partner with cross-functional teams including Quality, R&D, Clini...