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Roche Holding AG is seeking a Regulatory Affairs Specialist to manage the registration process for innovative medical products in compliance with NMPA regulations. The ideal candidate should have at least five years of experience in Medical Regulatory Affairs, particularly in IVD, and possess strong strategic and communication skills.
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Job Summary
You will drive the registration process for life-changing products ensuring full compliance with NMPA regulations.
The role involves actively participating in the formulation of national standards and providing feedback to authorities.
Roche is an Equal Opportunity Employer dedicated to advancing science and ensuring everyone has access to healthcare.
Matching Summary
Match Score: 75
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Roche Holding AG is seeking a Regulatory Affairs Specialist to manage the registration process for innovative medical products in compliance with NMPA regulations. The ideal candidate should have at least five years of experience in Medical Regulatory Affairs, particularly in IVD, and possess strong strategic and communication skills.
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Skills & Requirements
Must-have
5 years Medical Regulatory Affairs experience
Deep knowledge of NMPA regulations
Bachelor's degree in Medicine or Pharmacy
Nice-to-have
Background in IVD R&D or regulatory affairs
Experience drafting PTRs and managing QC type testing
Fluent English communication skills
Key Requirements
At least 5 years of experience in Medical Regulatory Affairs
Bachelor's degree or above in Medicine, Bioengineering, Clinical Medicine, Biochemistry, or Pharmacy