RA Manager, China
宾得医疗器械（上海）有限公司
- 公司规模：150-500人
- 公司性质：外资（非欧美）
- 公司行业：医疗设备/器械
职位信息
- 发布日期：2017-02-21
- 工作地点：上海-徐汇区
- 招聘人数：1人
- 工作经验：5-7年经验
- 学历要求：本科
- 职位月薪：2-2.5万/月
- 职位类别：质量管理/测试主管(QA/QC主管)
职位描述
职位描述：
Product registration:
1. Documents preparation;
2. Manufacturing site, Testing Center and CFDA communication;
3. Manage registration tests;
4. Manage consultants to lead consultant applications;
5. Registration database management.
Authority communication:
1. Authority training and meeting.
Handle other regulatory related tasks.
产品注册：
1、 文件的准备；
2、 与生产基地、检测中心和国家食品药品监督管理局的沟通；
3、 注册测试的管理；
4、 管理代理公司并领导代理申请的项目；
5、 注册数据信息的管理；
与国家食品药品监督管理局沟通：
1、 国家食品药品监督管理局组织的培训和会议；
处理其他任何与注册相关的工作
Top Three Main Qualifications which Candidates Must Have 候选人最需要具备的三个基本要求
1、No regular travel, biz travel could be <20%. 不需要定期出差，出差频率低于20%
2、CFDA and Testing Center visiting are needed (for submission, clarification, tests, etc.) 需要拜访国家食品药品监督管理局和检测中心（提交材料，解释澄清，检测等等）
3、No special requirements on working time. 工作时间没有特殊要求
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Product registration:
1. Documents preparation;
2. Manufacturing site, Testing Center and CFDA communication;
3. Manage registration tests;
4. Manage consultants to lead consultant applications;
5. Registration database management.
Authority communication:
1. Authority training and meeting.
Handle other regulatory related tasks.
产品注册：
1、 文件的准备；
2、 与生产基地、检测中心和国家食品药品监督管理局的沟通；
3、 注册测试的管理；
4、 管理代理公司并领导代理申请的项目；
5、 注册数据信息的管理；
与国家食品药品监督管理局沟通：
1、 国家食品药品监督管理局组织的培训和会议；
处理其他任何与注册相关的工作
Top Three Main Qualifications which Candidates Must Have 候选人最需要具备的三个基本要求
1、No regular travel, biz travel could be <20%. 不需要定期出差，出差频率低于20%
2、CFDA and Testing Center visiting are needed (for submission, clarification, tests, etc.) 需要拜访国家食品药品监督管理局和检测中心（提交材料，解释澄清，检测等等）
3、No special requirements on working time. 工作时间没有特殊要求
职能类别： 质量管理/测试主管(QA/QC主管)
公司介绍
As a wholly-owned subsidiary of the Japan Public Company, HOYA Corporation (Tokyo Stock Exchange, stock code 7741), Pentax Medical provides endoscopic imaging devices and solutions to the global medical community. We specialize in the development of video and fiber endoscopy equipment for observation, therapeutic and research applications in the GI, ENT and Pulmonary medical fields, offering a full range of products and services based on leading edge R&D and manufacturing.
Headquartered in Japan, we have a worldwide focus and presence with R&D, sales, service, and in-country facilities around the globe. Our employees represent the diverse countries where we do business, allowing us to provide innovative solutions tailored to meet local needs.
Headquartered in Japan, we have a worldwide focus and presence with R&D, sales, service, and in-country facilities around the globe. Our employees represent the diverse countries where we do business, allowing us to provide innovative solutions tailored to meet local needs.