Job Responsibilities:

1. Responsible for the registr暗現ation of new products, including t民那he entire planning proces麗麗s, data compilation, declar長對ation and tracking;

2. Lead or participate in the estab話舞lishment and maintenance of a quali家河ty management system ba道制sed on the company's o紅開verall development needs;

3. Responsible for manag笑輛ing the entire process of medical裡生 device registration application, maki從歌ng it standardized and standardized學事;

4. Responsible for communica來聽tion and coordination with external ag鐵路encies related to pro農草duct registration, such as t物看esting agencies, clin門電ical trial agencies, third-party certi呢計fication agencies, drug regul影樂atory departments, review在坐 centers, etc .;

5. Responsible for summarizing, clas會窗sifying, sorting, and filing vario兵窗us regulations and te器吧chnical standards issued 亮快by the drug supervisio子信n department;

6. Responsible for product pr外工oduction / operation licen長腦se, change and renewal of product re制吧gistration certificate.

job requirements:

1. Familiar with the laws and reg舞又ulations related to the門土 registration of Cla南懂ss II active instrument喝暗s and Class III in vitro diag雪些nostic reagents and re物他lated processes, and can i是件ndependently complete Clas了議s II active instruments (such as dry fl討計uorescent immunoassay analyzers) and說都 Class III IVD detection reagents (fl很匠uorescent immunoassay) Law) registra商校tion work;

2. Maintain close ties志數 with the drug supervi慢睡sion department, testing, c花通ertification, clinical an訊低d other related outreach or科黑ganizations and establish good re不錢lations;

3. Possess good quality and profe筆笑ssional ethics, communic老線ation ability, learning坐土 ability, teamwork a樹姐bility, strong sense of responsibil暗現ity, and strong stress微做 resistance;

4. Major in clinical m暗線edicine, biology, pharmacy, 花做etc., full-time undergraduate 城車degree or above;

5. Familiar with the GM站會P quality management system 鐘媽of medical devices, with YY / T0287 in錯飛ternal auditor qualification.

Resume email: HR@neogene.net