谢灵灵's Location
Fangshan District, Beijing, China, China
About 谢灵灵
医疗器械注册
谢灵灵's Current Company Details
北京优迅医疗器械有限公司
注册专员
谢灵灵 Work Experience Details
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注册专员北京优迅医疗器械有限公司 Jun 2021 - Present中国 北京市 大兴区负责三类伴随诊断试剂其中两家临床机构的临床试验工作。审核研发提供的注册资料并 提出修改意见，配合准备最终注册资料。负责三类诊断试剂的项目规划并和各部门同事合作推进进度。负责公司产品的CE注册。完成了4个产品的自我声明。准备C类产品的IVDR。
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法规质控工程师瞬知 Dec 2018 - Dec 2020中国 北京负责医疗器械产品注册，FDA认证，CE认证
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注册专员定向点金 Apr 2017 - Nov 2018中国 北京负责二三类IVD试剂的注册，包括与客户沟通产品信息，审核注册文件，收集、整理、翻译和编写相关资料等工作跟进检测、审评，完成注册；收集IVD注册方面的法规文件、参加相关培训、追踪最新法规及政策动态；编写临床试验方案，熟悉临床试验流程。
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技术部 主管深圳德夏科技发展有限公司 May 2013 - Jan 2016
Frequently Asked Questions about 谢灵灵
What company does 谢灵灵 work for?
谢灵灵 works for 北京优迅医疗器械有限公司
What is 谢灵灵's role at the current company?
谢灵灵's current role is 注册专员.
What schools did 谢灵灵 attend?
谢灵灵 attended 中南大学, 湖南师范大学.
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