Responsibilities
1. Plan and execute overseas product registration based on requirements and development processes.
2. Prepare and submit registration documents, track progress, and manage compliance responses.
3. Coordinate sample submissions, monitor approvals, resolve issues, and review reports.
4. Maintain registration records and archive documentation.
5. Track regulatory updates, conduct compliance training, and ensure R&D alignment.


Requirements
1. Bachelor’s+ in Biomedical/Mechanical/Electrical Engineering, Medical Devices, or related fields; CET-6+.
2. Proficient in GMP/QSR820/ISO13485; experienced in MDR CE/FDA registration and leading projects independently.
3. 3+ years in active medical device registration (Class II first-time success preferred); production license experience.
4. Certified in medical device registration & regulatory training.

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