职位描述:
工作内容：
1, 及时了解体外诊断试剂法律法规变化，整理更新；
2, 负责注册资料整理编写、报送、检验和注册进度跟踪；
3, 配合公司其他部门业务工作，为各部门提供法规和技术咨询，组织内部培训；
4, 和市场，销售，物流部门配合，协助新品上市；
5, 注册申报资料及补充资料的收集、整理、及存档；
6, 认真高效完成上级交办的其它任务。

1, Understand SFDA registration guideline change about IVD products and update accordingly
2, In charge of draft, compilation and submission of IVD registration dossier, follow and track the registration status in a timely manner.
3, Cooperate with other department to supply legal and technical consultation, organize corresponding internal training.
4, Closely work with marketing, sales and logistic team for all the RA issues to help the new products launch.
5, Sort and keep all relevant registration documentations including supplementary files.
6, Other works.


职位要求：
1, 大学本科或以上生命科学领域
2, 至少3年医疗器械或体外诊断试剂注册相关经验,有体外诊断试剂经验优先
3, 熟悉医疗器械或体外诊断试剂产品注册相关法律法规
4, 积极的工作态度，适应能力强，团队合作精神
5, 有较强的沟通协调能力


1 .Bachelor degree or above in pharmacy/pharmaceuticals/bio-chemistry or related science
2, Minimum 3 years of working experience in medical device or IVD registrations, with IVD experience is
preferable.
3, With knowledge and experience working with SFDA regulation and familiar with the registration application
procedure of SFDA and related laws
4, Positive attitude, flexibility, adaptability and team spirit
5, Good communication skills