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 Company/Dept. Name: Guangzhou T.K Medical Instrument Co., Ltd.
About Company
Guangzhou T.K Medical Instrument Co., Ltd. is a hi-tech company which is well-known for ongoing innovation in China. Former Premier Wen Jiabao visited T.K Medical on Sep. 12, 2005. Our company innovates, manufactures, and distributes medical devices, including devices used in minimally invasive surgery and sleep surgery.

   The management and technical team of our company consists of many excellent researchers who are creative, dynamic and highly motivated. The technical team has the capability to develop innovative products independently and has accomplished several key R&D projects from government funding. We have developed more than 300 patents.
 
 Contact Info
Address: A601 Guangzhou International Business Incubator, Guangzhou Science Park , Guangzhou , China Zip Code: 510765
Contact Person: Miss. Luo Tel: 020-37616967 Fax: 020-32290395
Email: hr@gtkmedical.com Website: www.tk-medical.com
 产品注册及体系工程师 Recruit number: 2 People Date Posted:Nov 10, 2020  

Job Label :

带薪年假定期体检年终奖金节日福利五险一金员工旅游周末双休专业培训包住包吃
Perfered Major:   Age Requirement:  Unlimited
Desired Education Level:  Bachelor Current Place:  Unlimited
Foreign Language:  English good Job Location:  Luogang  
Cantonese:  Unlimited Job Type:  Full time
Sex:  Unlimited Salary:  ¥5000~¥10000 
Marital Status:  Unlimited Tel:  
Contact Person:   Email:  
 
Job Responsibilities & Requirements
负责医疗器械产品的注册工作及研发体系管理工作。

岗位职责:
1、负责医疗器械产品注册文件的编写及申报工作;
2、负责跟进产品注册进度,包括注册检测、临床进度跟进等;
3、产品注册申报资料的整理和归档;
4、研发体系流程的制定、管理;
5、跟进项目研发流程的文控管理和相关文档编写。

岗位要求:
1、本科或以上学历,医疗器械、生物医学工程、计算机、电子信息等医疗器械相关专业;
2、英语四级及以上水平,英文文献阅读、撰写熟练,具有良好的文档编写能力;
3、熟悉医疗器械法律法规及产品研发流程,1年以上医疗器械质量体系与产品注册相关工作经验;
4、具备较强的沟通能力和解决问题的能力,有较强的责任心。