工作职责Responsibilities:
1、负责医疗器械国际市场准入和注册工作；
To undertake the medical device registration works in International area；
2、负责相关区域的医疗器械法规的研究分析和导入、产品注册资料的编写、收集、递交；
To undertake the analysis and implementation of related regulations and technical standards of medical devices; writing, collecting and submitting the registration dossier；
3、负责医疗器械注册过程中与注册顾问及相关监管机构的联络沟通；解决注册问题，推进注册进程、保证良好注册结果；
To maintain active communication with consultants, and relating authorities; solving registration problems, pushing forward the registration process and guarantee a favorable registration result。

职位要求Job Requirements:
1、电子、自动化类理工科专业背景，生物医学工程专业优先；
Major in electronics, automation engineering and biomedical engineering will be preferable；
2、有医疗行业法规注册相关工作经验优先（一类二类三类都可以）；
Working experience in medical device registration will be preferable；
3、具备良好的沟通合作的能力和团队合作精神，抗压能力强；
Excellent communication skills with team work spirit; ability to maintain good performance under pressure；
4、良好的英语读写能力；
Good communication skill includes English in reading/writing and oral。