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Principal Regulatory Affairs Specialist
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- Principal Regulatory Affairs Specialist
- Principal Regulatory Affairs Specialist (U.S. Hub based location)
- The Principal Regulatory Affairs Specialist will prepare comprehensive regulatory strategies for complex new devices and post market changes within our Ultrasound business.
- You will lead business critical new product development projects, provide regulatory oversight to maintain lifecycle ensuring that the state-of-the-art requirements are maintained; Develop regulatory strategies and communicate risks within regulatory strategies vs project plan, and outline proposal for balancing the project risk to project teams and Regulatory Affairs Management.
- You’ve acquired 7+ years of experience in Medical Device Regulatory Affairs, first line experience with U.S. FDA, China NMPA, and EU MDR is required.
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