主要职责Main responsibilities:
1 较好理解CFDA诊断试剂和仪器相关法规，追踪其变化。Well comprehend relevant CFDA IVD reagent and instrument regulations, track the developments.
2 负责进口体外诊断试剂和仪器的注册。Be responsible for import IVD reagent and instrument registration in CFDA.
3 组织实施注册检测和临床试验。Organize and implement registration tests and clinical trials.
4 根据注册计划，准备、提交注册资料，跟踪控制注册进程，尽早获得注册证书。Preparing product registration submission, tracking the process and obtain registration approval certificate as early as possible based on Registration Plan.
5 注册资料翻译。Necessary registration documents translation。
6 与生产厂RA合作获得必要的注册信息和资料。Cooperate with manufacturer RA to get necessary registration information and data.
7 归档、保管注册资料。File and maintain registration documents.
8 就法规事务事宜为其他部门提供支持Support to other functions on RA issues.
9 与有关职能主管部门保持积极有效的沟通Have active and effective communication with relevant competent authorities
10 完成QA&RA总监安排的其它工作。Executing other tasks assigned by QA&RA director.

工作经验Required Experience
1. 至少有1年医疗器械注册经验。Minimum 1 years working experience in medical device registration.
2. 有外企从事体外诊断试剂和仪器注册工作经验者优先。Working experience in IVD reagents and instruments registration in foreign company is a plus.

学历/资格要求Required Qualifications
学士及以上学位，医学检验、临床医学、卫生、生物学、生命科学、化学或相关专业。Bachelor's degree or above in Medical Inspection, Clinical Medical, Healthcare, Biology, Life Science, Chemistry discipline or related