北京招聘

工作职责:

1、根据公司注册规划，制订所负责项目的注册进度计划，并按计划推进执行

2、负责注册资料的准备及审查，确保准确性

3、跟进检测，及时了解和解决检测问题，在规定时间内完成检测

4、根据注册法规，在规定期限内完成资料发补等工作，直至取证

5、负责产品注册证维护工作，包括再注册，变更，说明书及标签等工作

6、检验注册证的到期情况，对注册证进行及时更新，确保注册证符合国家法规要求，杜绝过期风险

7、与业务部、市场部、技术服务部的配合工作

8、其它相关工作

任职资格:

1、本科及以上学历，工科类专业优先

2、具备医疗器械产品注册经验，熟悉并掌握中国医疗器械管理及注册等相关法规及技术指导原则，熟悉注册申报各环节

3、具有良好的申报资料撰写能力和对申报资料审核的能力

4、具有较强的独立工作能力及团队合作精神，高度的工作热情

5、具有良好的沟通、协调能力，以及项目管理能力

6、良好的英语能力

KARL STORZ公司1945年成立于德国西南部的图特林根市。经过70年的发展，目前已超过6400名员工，成立有50个分公司，在全球39个国家和地区设立有办事机构。产品销往全球超过150个国家和地区，营销网络遍布欧洲、美洲、亚洲、澳洲、非洲。公司业务线包括：人体医用微创设备和器械、工业内窥镜、兽医用微创设备和器械。经过全体KARL STORZ人的努力，我们已经是：
业界***一家生产全科内窥镜产品的公司
全球***微创外科内镜设备及器械制造公司
   
自2006年进入中国以来，已在上海、北京、广州、成都、沈阳、南京、西安和香港等地开设了办事处，服务于大中华区的客户。经过近10年的奋斗，KARL STORZ中国区同样硕果累累，在中国大陆地区取得的市场荣誉包括：
进口内镜品牌市场占有率***，获得中国手术内窥镜市场增长奖
一体化手术室市场占有率超过50%，获得中国一体化手术室市场领导奖
中国硬式内窥镜类售后服务满意度***名

作为专注于产品的家族企业，KARL STORZ一直致力于开发外科新产品，源源不断地将各类精密产品和优质服务推向全世界。同时通过和医学各学科的领军人物、各医科大学和科研机构人员接触并进行专业对话，不断革新微创产品、发展微创技术，为医生和病人的需求提供理想的解决方案。虽然锐意进取，但在国内和国际的竞争中，KARL STORZ始终奉行“以客户为重、质量先行”的宗旨，抵制所有的非法行为。

如果具备以下特质，欢迎您的加入：
突出的个体贡献者：在现有岗位上取得优异的业绩
积极的协作者与促进者：对周围同事提供支持和帮助，对组织创造价值
优秀的管理者：成功培育人才，带领团队产生高绩效
KARL STORZ公司将为优秀人才提供：
医疗行业内富有竞争力的薪酬福利体系
更多的学习发展机会
更多的岗位选择机会

投递简历后，如符合岗位要求，HR将于4周内联系您。如暂时没有合适您的职位，您的资料将自动转入人才库。在12个月内，如有合适的职位，HR仍有可能联系您。

Company:
Since its beginnings in 1945, the KARL STORZ family company has grown into a global manufacturer and distributor of endoscopes, medical instruments, and devices. They are not a giant on an international scale but a leader in the things that matter: creativity, flexibility, and expertise. The company’s endoscopy equipment includes over 15,000 products used in human and veterinary medicine as well as in industrial applications. The diversified product portfolio augments the company’s ability to register market leading growth by providing multiple sources of revenue. The most recent KARL STORZ developments are in digital documentation systems and comprehensive operating room concepts. As a system supplier, the company combines its expertise in endoscopy with software solutions to achieve integration in the operating room and to support clinical process and resource management. The company headquarters in Tuttlingen, Germany.

Products & Operations:
When KARL STORZ started to take an interest in endoscopy about 70 years ago, few specialties used endoscopes. That has changed radically. Thanks in part to dedicated KARL STORZ development work throughout recent decades, virtually every medical specialty can today benefit from endoscopic and minimally invasive procedures. The overview of the product range therefore literally reaches from head to toe, and with a steadily growing portfolio, it also extends to the large sectors of veterinary medicine and industrial endoscopy.
As a global family company, KARL STORZ is active worldwide to support and consult customers around the globe. Across all continents, KARL STORZ is represented by more than 50 KARL STORZ subsidiaries in 39 countries.
KARL STORZ China’s Head office is based in Shanghai along with branches in Beijing, Guangzhou, Chengdu, Shenyang and Hong Kong. As part of its international market, KARL STORZ China has experienced significant growth over the past five years, and will continue to grow.
To learn more about KARL STORZ and their product offerings, please visit their website at ************************/.