Principal Regulatory Affairs Specialist
Philips(3 months ago)
About this role
The Principal Regulatory Affairs Specialist will lead regulatory strategy and support new product development and lifecycle activities for Sleep & Respiratory Care products with a primary focus on Software as a Medical Device (SaMD) across the U.S., EU and other global markets. The role is based at Philips and partners with cross-functional teams to ensure products meet regulatory and compliance requirements from concept through delivery and post-market.
Required Skills
- Regulatory Strategy
- Regulatory Submissions
- SaMD
- 510K
- EU MDR
- Pre-Sub
- SDLC
- IEC 82304
- IEC 81001-5-1
- ISO 27001
+5 more
Qualifications
- Bachelor's Degree
- RAPS (Preferred)
- US Work Authorization (Required)
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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