北京招聘

这是一家美资世界500强外企、世界医疗器械行业十强企业，年营业收入达100亿美元，全球43,000名员工生产50,000种医疗产品。其使命是维护与医疗专业人士合乎道德的合作，创造并提供创新的医疗解决方案，从而提高患者的生活质量，同时增加客户以及股东的收益。

为了更好的开展工作，现受其委托招聘。

Job title: RA Specialist

Role & Responsibilities：

1. Member of EM R&D project team to deliver regulatory input by leveraging all resources available.

2. Outline the regulatory requirements associated with quick win projects or specific projects including providing regulatory counsel at the team meeting and identifying the need for regulatory involvement.

3. Co-ordinate and communicate with project team to work out the registration time schedule according to Product Development Procedure in place.

4. Keep contact with EM RA group to formulate the registration strategy, prioritize each country submission to meet up with the goal of Time to Market.

5. Take care of the project from Concept to Commercialization to provide any regulatory guideline, to review and release the project file if required.

6. Prepare and release the Registration Application Dossier to facilitate the move-on of project and to ensure the regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability.

7. Responsible for assessment of device changes for regulatory implications after launch, support the documents required and update & track the registration if necessary.

8. Set up & maintain the medical regulation matrix within EM, keep abreast of amendments/changes to regulations and guideline, and evaluate & update the project team the relevance or impact of the changes of regulations.

Requirements：

1. 本科及以上学历，法律、医学、机械、等医疗相关专业；

2. 具有3年及以上医疗器械或制药相关注册经营，掌握医疗器械注册的相关工作流程；

3. 具有良好的沟通能力和协调能力，具有一定的注册项目管理能力，组织计划能力，能有效解决问题；

4. 英文听说读写能力熟练，有良好的团队精神

Registration experience on CE mark, 510K or registration outside of China is preferred；Experienced work with engineers of CFDA accredited testing institutes or qualified test lab is preferred.

工作地点：浦江镇（地铁8号线直达）

工作时间：做五休二（常日班）

福利待遇：培训+工作餐+班车等

世界500强外企工作环境等待你的加入，2014年新起点，期待你的投递。

如有任何问题可以发mail至 vina.chen@randstad.cn 或通过tel 60868792联系我们的招聘顾问 Vina Chen。