1. Support RA project owner maintain current NMPA approved certificates, including extension registration, change registration and support BU&RC to resolve post-marketing issues.
2. Support RA project owner on new products launch in China, including, type test, prepare registration documents, etc..
3. Host regular meeting with WW to get requested documents and update registration status.
4. Other affairs within the team.
1.Medical/Pharmacy background, or relevant experience on regulatory affairs
2.Bachelor degree or above
3.Proficient in spoken and written English and Chinese
4.Excellent interpersonal and communication skills
1.支持RA项目所有者维护当前NMPA批准的证书，包括延期登记、变更登记，并支持BU和RC解决上市后问题。
2.支持RA项目所有者在中国推出新产品，包括型式试验、准备注册文件等。
3.与WW定期举行会议，以获取所需文件并更新注册状态。
4.团队内部的其他事务。
1.医学/药学背景，或监管事务相关经验
2.本科及以上学历
3.精通中英文口语和书面表达
4.优秀的人际关系和沟通能力
职能类别：医疗器械注册
关键字：英语理工科医疗器械
英语精通