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  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述: 工作职责:1、负责组织相关部门按法规要求整理撰写体外诊断试剂的申报资料; 2、负责临床法案撰写,临床试验研究、临床基地调研及初步筛选,协调临床试验各阶段会议及临床试验进度; 3、负责产品申报的送审与注册登记工作,及时追踪、汇报注册进度; 4、负责研发过程中疑难问题的收集、整理、咨询、反馈; 5、负责整理、审核申报资料,保证其完整性、正确性,并做到及时归档; 6、负责收集医疗器械注册相关的行业动态、法律法规、相关政策及技术指导原则等; 7、负责注册主管部门评审专家的沟通及维护; 岗位职责:1、大学本科以上学历,或中级以上专业技术职称,具有相应的专业知识(细菌学、病毒学、生物学、分子生物学、生物化学、免疫学、医学、药学等); 2、3年以上三类医疗器械注册经验; 3、熟悉注册相关的法规、注册流程; 4、有分子诊断背景的优先考虑; 5、责任心强,具有良好的沟通、协调能力、团队合作精神,执行力强。 职能类别: 药品注册 关键字: 注册 三类 诊断试剂

联系方式

张江高科技园区

公司信息

Established in 1997 by Mr.Liu Yan (刘岩), GEN is an HR service company specializing in recruiting talented individuals for upper and middle level positions with our clients. Headquartered in Shanghai, and with branch offices in Suzhou (Jiangsu province), Zhengzhou (Henan province), Beijing and Chengdu (Sichuan province), GEN employs a total of 100 employees. Since 2010, our business has gone through four years of continuous development, with 100% of our revenues coming from headhunting services. As a perennial member of the Shanghai Talent Association, in 2013 GEN was awarded recognition for an 'Excellent Enterprise' within Shanghai's Songjiang District. The same year, we were credited as 'Shanghai Trustworthy Talent Service Agency'. In China, GEN provides its clients with high-level strategic and middle-level management personnel, as well as with technical and specialist candidates (eg.Chief Officer, General Manager, Director, Department Manager and Senior Supervisor, Engineers etc.). Rely on our extensive database, we can offer our clients HR services within the Asia Pacific region. Our main focus industries are automotive, chemicals&pharmaceuticals, machinery manufacturing, telecommunications, finance, software&Internet, electronic&electrical, consumer goods, 3rd party services (IT/logistics/ERP Consulting) and real estate management. We are especially adept at finding candidates for positions in Operation Management, Sales&Marketing, Finance, Project Management, Investment, Supply Chain, HR&Administration, R&D, Production Control, Quality, EHS, Testing, IT/IT System Integration, ERP Consulting, Customer Service, Clinical Research, New Drug Registration etc. For many years we have loyally followed our business service ideals: westrive topromote the development of China's human resources, at the same timeguiding our employees in knowing the right from wrong, distinguishing the good from the bad, and promoting the polite conduct. 上海泽恩实业有限公司由刘岩先生创办于1997 年,是专业从事中高级人才代理招聘服务的人力资源服务型企业。公司总部位于上海,目前在苏州、郑州、北京、山东四地设有分部,共计100 余名员工。2010 年起,业务收入连续破千万。其中人才代理招聘业务占总收入100%。作为上海人才协会的常年理事级单位,2013年、2016年被评为上海市区级优秀企业。2013年、2014年、2015年、2016年连续四年获得“上海市信得过人才服务机构”的荣誉称号。2015年荣获上海人力资源服务业“百强”机构荣誉称号。并获得上海人才协会授予《高级人才寻访服务规范》国家标准贯标单位及《高级人才寻访服务质量与评价要求》地方标准贯标单位称号。 泽恩实业在中国地区为客户提供理想的高级决策人才、中级管理人才以及基层技术和专业人才(如:首席官、总经理、总监、部门经理和高级主管、工程师等人选)。通过资讯平台,同时也为客户提供亚太区的人力资源服务。所擅长的领域主要有汽车、化工医药、机械制造、通信、金融、软件互联网、电子电气、快/耐消费品、制药、第3方服务(IT、物流、ERP咨询)和房地产管理等。所擅长的职能涵盖经营管理、销售、市场、财务、项目管理、投融资、供应链、人事行政、研发、生产管理、质量、安全健康环境、测试、IT/IT系统集成、ERP顾问、客户服务、临床研究、新药注册等。 泽恩实业多年来秉承“泽入四海源于己,恩出九天本在人”的核心思想不断奋进、锐意进取。以肩负“撬动中国人力资源”为使命,教导员工“知是非、识好坏、懂礼貌”,“为实现人力资源事业而奋斗”。 当接到通知来我公司面试时请带好中英文简历,身份证复印件,一寸照片1张。 人才中介服务许可证号:205

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