注册专员 苏州

月薪： 4-8千/月

该公司所有职位
  • 无工作经验
  • 招1人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 员工旅游
  • 餐饮补贴
  • 专业培训
  • 年终奖金
  • 弹性工作
  • 定期体检

职位描述

职位描述： 岗位职责：1、负责医疗器械申报资料的撰写、整理和内部审核；2、负责注册项目的统筹、协调及项目进度跟踪；3、与药监主管部门和医疗器械评审中心的沟通协调；4、协助建立注册团队的工作系统和程序以确保项目在规定时间内及时完成；5、及时汇总、分类、整理、归档国家药品监督管理部门出台的各项药事法规、文件、技术资料。任职资格：1、生命科学相关专业本科或以上学历，从事医疗器械注册工作1年以上；2、熟悉医疗器械管理及注册法规，能独立处理、解决医疗器械注册过程中出现的问题；3、熟悉医疗器械注册申报流程和各个环节；4、熟悉医疗器械注册法规，掌握荧光定量PCR或免疫组织化学基本理论知识，能独立汇总审核医疗器械申报资料；5、对注册信息以及相关的产品资料负有保密责任；6、具有较强的文献检索能力，沟通及协调能力，与相关部门保持良好沟通。 职能类别： 医疗器械注册

联系方式

苏州工业园区星湖街218号生物纳米园B5楼901室

公司信息

QIAGEN (Suzhou) Translational Medicine Company, is a new innovative company that provides a unique one-stop-shop of biotechnological Research & Development services to the healthcare industry in China and worldwide. The company was founded in 2012 through the collaboration of two distinguished entities in the biotechnology industry; QIAGEN N.V., leader in sample & assay technology and BioBAY, an innovative science and technology carrier for development of the emerging biological industry. QIAGEN (Suzhou) Translational Medicine Company, supplies our partners, with solutions to develop their capabilities and products, in order to serve their patients with the latest development in life sciences. The company`s business scope is to provide molecular biomarker discovery, validation and assay development, companion diagnostics development and commercialization. The company is constituted of a two thousand square meters “State-of-the Art” facility and equipped with the most advanced technology. It is located in the heart of BioBAY`s campus, situated in Dushu Lake Science and Education Innovation District of Suzhou Industrial Park.

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