• 3-4年经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述: 工作描述:1、承担二类、三类进口有源设备、耗材、无源耗材、植入物的申请资料制作、编辑和整理、资料补充,直至领取批件;2、与总部沟通协调,获取注册所需信息和资料;3、就补充材料通知要求,主动与CFDA沟通,确定审评具体要求,明确补充思路;4、与检测中心沟通,解决检测中遇到的具体问题,跟踪检测进度,直至取得检测报告;5、与地方市场部沟通,明确需求,落实到注册资料的具体准备中;6、熟悉掌握公司合规流程,严格执行《注册工作指导要求》的规定;7、积极主动向经理汇报工作进展,明确遇到的问题,寻求帮助;8、参加与BU/DP的例会,更新项目状态,明确下一步行动计划及预计时间。岗位要求:1、大学本科以上学历,理工科专业背景优先。2、四年以上进口有源无源医疗器械注册经验,熟悉CFDA医疗器械法规,能独立承担各种类型(首次,变更,延续等)的注册任务。3、沟通意识强,有较好的沟通能力,善于学习。4、英语听说读写能力良好,可独立与总部沟通。 职能类别: 医疗器械注册

联系方式

北京市

公司信息

More than the opportunity of a lifetime...... the opportunity to improve lives. For more than 30 years, Boston Scientific has advanced the practice of less-invasive medicine. The Company's products help physicians and other medical professionals improve their patients' quality of life by providing alternatives to surgery. Since 1994, employees in Galway, Ireland have been at the forefront of some of these truly innovative medical device designs and manufacturing. Some facts about us: -    One of the world's largest medical device companies dedicated to less-invasive medicine -    Offering breakthrough medical innovations for more than 30 years -    More than 25,000 employees -    13 manufacturing facilities worldwide -    Portfolio of more than 13,000 products -    Investment of $1 Billion in Research and Development annually with over 150 R&D products in the pipeline15,717 patents issued worldwide (cant verify this fact) -    Clinical Science group has approximately 75 active or planned clinical studies Boston Scientific Foundation has awarded more than 85 community grants and 100 medical fellowships in 2010 We have created a five-year strategic plan, POWER, designed to successfully address the future global healthcare landscape and increase profitable growth. A key focus area of the strategy is to win global market share, particularly in the Emerging Markets.We have announced a five-year, $150 million investment in China designed to reinforce our commitment to one of the world’s largest and fastest growing medical device markets. This investment will enable us to establish a local manufacturing facility in China and develop a world-class training centre for Chinese healthcare providers. In addition, , we are expanding our sales force, and growing our R&D and clinical capabilities to better bring our life-saving products to customers and their patients. Due to our start up initiative in China, we are seeking for top talents who are fluent Mandarin & English speakers to join us. A 3-6 month training program in Galway, Irelend would be offered to some positions in 2012. 这不仅仅是一次千载难逢的好机会。。。。。。更是一次可以为提高大众生活品质做贡献的机会。 近30年来,波士顿科学(以下简称波科)在微创领域一直处于领先地位。公司的产品帮助了医生和医疗人员,替代开放型手术,提高了病人的生活质量。自1994年始,爱尔兰戈尔韦最为波科生产基地,成为了在该医药器械制造和创新领域的前沿阵地, 请关注以下波科的事实: -    作为世界最大的医疗器械公司之一,致力于微创医疗 -    近30年来在医疗创新中取得了突出的贡献 -    拥有超过25,000名员工 -    在全球有13个生产制造基地 -    超过13,000多种产品 -    在研发领域每年投资超过150亿美元用于超过150种产品的研发,并在全球拥有15,717个专利 -    临床研究团队拥有大约75个在进行及计划中的临床研究 波科基金在2010年资助了超过85个公共助学金和100个医学类奖学金。我们也建立了新的5年策略,POWER,在利润增长的同时对全球医疗蓝图做了成功的规划。该策略的关键是赢得全球市场,特别针对全球新兴市场。我们已经宣布在近五年内,对全球最大、发展最快的医疗器械市场,中国,投资1.5亿美金,这是我们对全球新兴市场的一记“重拳”。该投资将帮我们在中国建立制造中心和建立一个世界级的培训中心。此外,我们的销售团队也会扩容,并建立研发和临床研究团队,以帮助我们为我们的客户和他们的病人提供更好地产品和服务。 鉴于以上我们在中国的举措,我们需要招聘英语流利的高端人才加入我们的团队共同实现目标。某些职位将在入职后赴爱尔兰的戈尔韦参加为期3至6个月的培训。

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