- Execute Medical Device post market Adverse event report and Advertisement submittion per CFDA Regulation.
- Ensure that corporate and local procedures are followed.
- Coordinate AE reporting process with CA and on-time report both domestic and worldwide Adverse Event according to CFDA regulation.
- Coordinate Advertisement review process with Market, divisions, Compliance, driving advertisement submitting and compliance to regulation. Achieve related performance metrics.
- Coordinate the AE investigation with Cook Manufacturers, follow up case investigation and on time close AE case in CFDA ADR system.
- Participate in internal and external audit.
- Have a sound understanding of, and comply with, the COOK Code of Conduct and Company Compliance requirements
- Relevant college/university degree is essential.
- Basic Statically analysis skill
- Fluent English both in writing and oral
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