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无工作经验 -
招1人 -
11-09 发布
职位描述
职位描述： 主要职责Main responsibilities:1较好理解CFDA诊断试剂和仪器相关法规，追踪其变化。Well comprehend relevant CFDA IVD reagent and instrument regulations, track the developments.2负责进口体外诊断试剂和仪器的注册。Be responsible for import IVD reagent and instrument registration in CFDA.3组织实施注册检测和临床试验。Organize and implement registration tests and clinical trials.4根据注册计划，准备、提交注册资料，跟踪控制注册进程，尽早获得注册证书。Preparing product registration submission, tracking the process and obtain registration approval certificate as early as possible based on Registration Plan.5注册资料翻译。Necessary registration documents translation。6与生产厂RA合作获得必要的注册信息和资料。Cooperate with manufacturer RA to get necessary registration information and data.7归档、保管注册资料。File and maintain registration documents.8就法规事务事宜为其他部门提供支持Support to other functions on RA issues.9与有关职能主管部门保持积极有效的沟通Have active and effective communication with relevant competent authorities10完成QA&RA总监安排的其它工作。Executing other tasks assigned by QA&RA director.工作经验Required Experience1. 至少有1年医疗器械注册经验。Minimum 1 years working experience in medical device registration.2.有外企从事体外诊断试剂和仪器注册工作经验者优先。Working experience in IVD reagents and instruments registration in foreign company is a plus.学历/资格要求Required Qualifications学士及以上学位，医学检验、临床医学、卫生、生物学、生命科学、化学或相关专业。Bachelor's degree or above in Medical Inspection, Clinical Medical, Healthcare, Biology, Life Science, Chemistry discipline or related 职能类别： 医疗器械注册
联系方式
北京市朝阳区酒仙桥路10号恒通商务园B18B座201
公司信息
Werfen Group is an international healthcare corporation, comprising a group of leading manufacturing and distribution companies. The group is active worldwide in several areas: in-vitro diagnostics, medical devices for the hospital and scientific instruments for industry and research. Since its founding in 1966 Werfen Group has fully embraced the concept of partnership, continuously leveraging its strengths, resources and commercial possibilities through acquisitions, distribution agreements and strategic alliances. 沃芬集团成立于1966年，总部位于西班牙巴塞罗那，专业从事供医院用的医疗器械和体外诊断试剂、供工业和研究用的科学仪器的研发、生产和销售，在25个国家和地区建立了分公司，全球有超过16000名员工。 2002年在上海成立沃芬医疗设备国际贸易（上海）有限公司，2009年在北京成立分公司。 沃芬医疗医疗器械商贸（北京）有限公司是一家专业从事医疗检验产品的西班牙独资公司。近年来，沃芬集团十分重视对中国的投入，中国已成为其全球策略的一个重要部分。 我们诚邀充满激情，实干的精英加入我们的团队。 如有相关从业经验或能胜任相应工作 请将个人简历投递E-mail: hr@werfen-china.com
