RA specialist II_ Project job opportunity at Abbott.

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DatePosted 4 Days Ago bot
Abbott RA specialist II_ Project
Experience: General
Pattern: full-time
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degreeGeneral
loacation China - Hangzhou, China
loacation China - Hangzh..........China

      JOB DESCRIPTION: 主要职责/Key Responsibilities： 1. 根据注册目标，执行IVDR 注册计划，及时跟踪IVDR 注册工作的进展，确保注册目 标完成； 2. 作为RA 代表参与公司新产品开发项目，输入法规策略，并持续跟进项目，确保产 品注册目标完成； 3. 协调完成国内及国际临床相关事宜； 4. 协助完成国内新产品注册递交及延续，变更事宜； 5. 收集体外诊断试剂相关国家法规和标准的要求并跟踪其发展动态，组织相关人员及 时在公司内部转化并贯彻实施，如有必要则组织相关培训，以确保公司的产品符合 法规、标准的要求； 6. 收集国家盘的更新，并协调完成国家盘的更新工作； 7. 协助上级制定团队目标并指导团队成员的业务开展。 8. 完成其他上级交办的工作任务 任职资格/Job Requirements： 1. 资格证书/Certificate： 没有资格证书要求，有项目管理资格认证证书优先 _________________________ 2. 外语技能/Foreign Language Skills： 英语读写良好，及良好的英语听说能力 _________________________ 3. 计算机软件技能Software Skills： 能熟练的操作OFFICE 软件 ________________________ 4. 工作经验或专业背景/Work Experience or Professional Background： 1 年以上药品或医疗器械注册或临床管理工作经验，有医院临床实践经验者优先 _________________________ 5. 教育背景/Education Background： 大学本科及以上，医药、生物、临床医学等相关专业背景优先 _________________________ 6. 其它要求/Others： 较强的分析和评估能力；较强的判断力和解决问题的能力；良好的沟通协调和抗 压能力;快速反应，高执行力，同时具有主动性和灵活性       The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.       JOB FAMILY: Regulatory Operations       DIVISION: ID Infectious Disease          LOCATION: China > Hangzhou : #198 12th Street, Hangzhou Economic & Technological Development Area       ADDITIONAL LOCATIONS:       WORK SHIFT: Standard       TRAVEL: Not specified       MEDICAL SURVEILLANCE: Not Applicable       SIGNIFICANT WORK ACTIVITIES: Not Applicable                  

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