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BD (Becton, Dickinson and Company) 高级法规事务专员_RA_北京 in Beijing, China

Job Description Summary

工作职责:

 负责所分配业务部产品全生命周期的法规相关事务,包括:

  • 负责所分配业务部的新产品注册申报工作、起草并整理相关申报资料,妥善保管注册文件;

  • 负责所分配业务部已有产品的延续注册和变更注册;

  • 协助所分配业务部的产品检测,负责解决检测过程中发生的问题;

  • 保持同有关政府部门的联系和沟通,跟踪审批情况,协调相关工作;

  • 保持同所负责业务部产品线相对应的境外合作伙伴的联系和沟通,获得相应支持;

  • 负责所分配业务部产品批准上市后的法规支持,解决后市场监察相关问题。

 协助法规事务经理制定所分配业务部的产品的年度预算计划;

 协同市场部门制定所分配业务部的产品上市时间表;

 协助法规事务经理做部门内部的活动计划。

能力要求:

 较强的口头表达能力和文字编辑能力;

 良好的人际沟通和组织协调能力,具有团队合作及开拓创新精神;

 能够阅读和理解专业英文资料;

 擅于沟通协调,能够独立处理突发问题。

任职资格:

 医药类专业本科以上学历,英语四级以上水平,能使用英语翻译文献资料;

 熟悉医疗器械法规,两年以上医疗器械注册经验;

 一定的注册项目管理能力,有效解决问题, 组织计划能力;

 工作态度积极主动,责任心强并具有良好的职业道德及敬业精神。

Job Description

Primary Work Location

CHN Beijing - BARD

Additional Locations

Work Shift

BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.

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