Major Responsibilities (工作职责):
1.Participation as Regulatory Affairs Part in local R&D projects (R&D China).参与中国本地研发项目的法规事务
2.Preparation and maintenance of STED documentation (and other registration documentation) on products produced in China.为中国工厂生产的产品准备和维护STED文档（和其他注册文档）
3.Evaluation and implementation of Engineering Change Orders (ECO) on products produced in China (where design responsibility is handed over to R&D China).评估和执行中国生的产品的ECO更改单（当设计转由中国当地研发部门负责时）
4.Registration on selected markets. 其他国家注册
5.Support Regulatory Affairs in Denmark on regulatory projects relevant for products produced in Ambu China.为丹麦总部的法规事务工作提供支持
Key Requirements (职位要求):
1.Bachelor’s Degree in any science discipline理工科学士学位
2.Experienced in regulatory affairs 朋从事法规事务的相关经验
3.Excellent communication skills both orally and verbally in English and Chinese
英语口语流利
4.knowledge in FDA 21 CFR 820 具有FDA 21 CFR 820 知识
5.knowledge in the Chinese & international Regulations 具有中国和国际法规知识
6.Certified ISO13485 internal auditor 具有ISO13485内审员证
