Responsibilities
1. Prepare and submit product registration documents, track inspection progress, and ensure timely certification.
2. Liaise with regulatory/testing agencies to resolve registration issues and secure approvals.
3. Maintain and archive registration records per document control procedures.
4. Monitor and analyze new medical device regulations/standards for compliance.
5. Manage production licenses, business records, and registration certificate applications/renewals.
6. Report adverse events through the national monitoring system.
7. Fulfill other assigned regulatory tasks.


Requirements
1. STEM bachelor’s degree+.
2. Proficient in GMP/ISO13485 & NMPA registration.
3. 3+ years’ active medical device registration experience (Class II first-time success preferred; sterile device experience a plus) , medical device production license experience.
4. Certified in medical device registration & regulations.

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