德国生物科技集团 RA Specialist
万宝盛华企业管理咨询(上海)有限公司
- 公司规模:1000-5000人
- 公司性质:外资(欧美)
- 公司行业:中介服务
职位信息
- 发布日期:2021-01-13
- 工作地点:北京-东城区
- 招聘人数:若干人
- 工作经验:1年经验
- 学历要求:本科
- 职位月薪:6-8千/月
- 职位类别:医疗器械注册
职位描述
Job Description:
1.Coordinate, prepare, or review regulatory submissions for international projects.
2.Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
3.Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
4.Prepare or maintain technical files as necessary to obtain and sustain product approval.
5.Coordinate efforts associated with the preparation of regulatory documents or submissions.
6.Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
7.Maintain RA database if there are new information
Requirements:
1.Bachelor or Master degree in medical background
2.Prefer for 1 year’ experience related to regulatory affairs
3.Good English both oral and written
4.Working Computer Operation skill
5.Experience working in a complex and matrixed environment is required
6.Up to date knowledge of regulations / guidance / national or industry standard
7.Team spirit . Self-motivated
公司介绍
联系方式
- Email:manpowerrecruiting@163.com
- 公司地址:华苑产业园海泰大道