Regulatory Affairs Specialist I
About this role
About the Role 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 opportunity to develop expertise in medical device regulations, including FDA regulations, EU MDR requirements, and international regulatory processes. What You'll Do
- Provide support for 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.
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