• 1年经验
  • 本科
  • 招1人
  • 11-21 发布
  • 五险一金
  • 补充医疗保险
  • 员工旅游
  • 年终奖金
  • 出国机会
  • 专业培训
  • 餐饮补贴
  • 弹性工作
  • 定期体检

职位描述

职位描述: 岗位职责:1.收集、解读东南亚各国/地区的注册相关法规(如新加坡、中国台湾等)Search and maintain knowledge and understanding of regulatory requirements in nations/region of Southeast Asia, Singapore, Taiwan ect.2.根据注册计划,与总部进行沟通,获得相关注册资料。Independent and timely communication between the headquarters. Get documents and samples of new raw materials for registration in accordance with the plan based.3.负责组织各部门完成中国产品的CE认证工作,根据CE协调指令编制CE技术文档。Write CE Technical File and get CE mark for local products4.协助注册部完成二类产品的注册工作Assist RA Dep. to get registration license for Class II products.岗位要求:1.文化程度Education:大学本科或以上学历,医药学、工学或相关专业Bachelor degree or above of medicine & pharmaceutical, engineering or related area2.精通英语good at writing, reading and speaking in English或把您的简历发至: hr_ehz@oumeng.com.cnOr you can email to : hr_ehz@oumeng.com.cn 职能类别: 医疗器械注册

联系方式

龙井路

公司信息

EUROIMMUN was founded in September 1987 and today has its headquarters in Lübeck, Germany. EUROIMMUN produces reagents for medical laboratory diagnostics. In the foreground are test systems for the determination of various antibodies in patient serum in the diagnosis of autoimmune diseases, infectious diseases and allergies. The company is based on worldwide-patented state-of-the-art production methods and microanalysis techniques and is one of the world's leading manu¬facturers of medical laboratory diagnostics. The company’s reference laboratory is unequalled in the whole field of autoimmune diagnostics. It helps EUROIMMUN customers to secure their results. With their quality and standardization, EUROIMMUN products are capturing the leading position in the world. EUROIMMUN embarked China in 1999. The Beijing office has now become the headquarters of EUROIMMUN Asia Pacific. The company sets high-standard research and production base in China and Singapore. Its sales teams cover most Asia-Pacific countries and regions such as China’s mainland, ChinaHong Kong, ChinaTaiwan, South Korea, Singapore and Thailand. With numerous global patents, state-of-the-art technology and clinical diagnostics techniques, the company wins high recognition from here and has become the leader of Asian market. 欧蒙医学实验诊断股份公司由德国吕贝克大学病理学教授Winfried Stöcker博士创建于1987年,是世界领先的医学诊断试剂及自动化仪器研发与生产的跨国企业。逾两千名员工服务于全球近200个国家及地区,其产品和服务惠及世界五大洲数万间实验室。欧蒙集团在自身免疫性疾病、感染性疾病、变态反应性疾病诊断领域拥有领先的诊断方案,在分子诊断及抗原检测等领域拥有先进的技术。同时,专业的欧蒙参考实验室为全球用户提供疑难样本的诊断和验证服务,由德国DAP(德国实验室认证机构)认证的欧蒙全球质量评价项目为广大客户提供全球实验室质量交流平台,助力客户加强实验室质量管理。 欧蒙医学诊断(中国)有限公司于1999年成立于北京,是欧蒙亚太集团总部。公司在中国、新加坡建立有先进的产品研发和生产基地,专业技术团队遍及中国各省市、中国香港、中国台湾、韩国、新加坡、泰国等亚太国家及地区。凭借提供高品质、全方位的医学诊断方案,秉承科技创新造就卓越品质,欧蒙诊断促进人类健康的企业宗旨,欧蒙的技术、产品与服务赢得了亚太地区客户的高度认可与信赖,成为医学诊断市场的领导者。

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