Regulatory Affairs Specialist
Philips(2 months ago)
About this role
A Regulatory Affairs Business Specialist supporting regulatory compliance for medical devices by translating regulatory requirements into business-aligned options and contributing to product lifecycle decisions. The role works with cross-functional and regional teams to align on global regulatory standards and supports organizational readiness for inspections and registrations. It operates at a moderate scope of complexity and provides informal guidance to junior colleagues.
Required Skills
- Regulatory Strategy
- Regulatory Submissions
- Risk Assessment
- Labeling
- Change Management
- UDI Management
- Clinical Investigations
- FDA Knowledge
- MDR Knowledge
- Audits
+4 more
Qualifications
- Bachelor's Degree
- Master's Degree
- Regulatory Affairs Certification
About Philips
philips.comLearn more about Philips and how we help improve people’s lives through meaningful innovation in the areas of Healthcare, Consumer Lifestyle and Lighting.
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