北京招聘

JD:
1、Work with Global RA team to ensure maintenance of existing registration license and timely registration of new products;
2、Establish medical business company quality procedures to ensure that all procedures are in compliant with China GSP;
3、Set up and maintaining controls and documentation procedures;
4、Collect post market vigilance data and report AE/SAE according to NMPA related regulation
5、Closely collaborate with other functions
6、The other regulatory tasks assigned by leader
Required:
1、At least 5 yearsworking experience as regulatory and quality or relevant in medical device company, independent and complete NMPA product registration experience of Class II or III active medical device is necessary；
2、Be familiar with NMPA medical devices registration regulations , guidelines and standards；
3、Be familiar ISO13485 quality management system, also China GSP requirements；
4、Fluent oral and written in English

Topcon是一家拥有90年历史的眼科产品专业公司。
在视光、眼科诊断与治疗及数据管理领域始终处于全球领先地位。全世界***台3D-OCT、全世界***台扫频源OCT以及多点扫描激光均由Topcon多项专利技术自主研发生产，为眼科的诊断治疗提供了先进的技术保障。随着人口老龄化和人口的增长，眼疾患日益增多，为了解决这一问题，我们更加关注眼健康，对眼病筛查、早期诊断、治疗提供相应的软硬件解决方案---可信赖的设备及安全的数据管理。“Your Vision, Our Focus”是Topcon公司一直以来的宗旨。