济南 [切换城市] 济南招聘济南生物/制药/医疗器械招聘济南医疗器械注册招聘

法律事务专员

锐珂医疗-研发中心

  • 公司规模:500-1000人
  • 公司性质:外资(欧美)
  • 公司行业:医疗设备/器械

职位信息

  • 发布日期:2016-11-06
  • 工作地点:上海-浦东新区
  • 招聘人数:1人
  • 学历要求:本科
  • 职位月薪:20-30万/年
  • 职位类别:医疗器械注册  

职位描述

职位描述:
工作职责
1. 建立和实施企业的监管政策和程序,以确保符合适用的国际法规和标准;
2. 与内部监管资源、外部经销商和外部顾问合作,达到卫生部代理产品的注册要求;
3. 就卫生部的要求提供指导,以取得在产品要出售的所有国家的销售许可;
4. 协助医疗器械法规的培训;
5. 按要求使产品注册和招标投标活动的文件合法化;
6. 为国际卫生部的产品注册/批准准备卷宗;
7. 维护文档系统,以确保 Carestream 的所有伙伴(监管、销售、营销等)有权获得卫生部注册、销售和营销支持所需的登记、牌照、许可证

任职资格
1. 理科、工程、国际商务、外语或其它相关学科的学士学位或同等经验;
2. 良好的英语和普通话交流能力;
3. 至少有3 – 5 年法规事务部的工作经验;
4. 有医疗行业相关经验者优先考虑;
5. 具备优秀的分析思维和解决问题的技能;
6. 高效地排定工作任务和目标的优先次序,有效的时间管理;
7. 具有团队精神;

职能类别: 医疗器械注册

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公司介绍

Carestream Health公司成立于2007年,是位于加拿大多伦多的Onex公司收购伊士曼柯达公司医疗集团后组成的。2011年的总收入近25亿美元。

Carestream Health公司拥有8,100多名员工,为全球150多个国家的数万名客户提供优质的医疗产品。公司拥有1,000多项技术专利,产品在全球90%的医疗机构中运转。在医疗信息管理解决方案(Carestream Solutions),数字获取解决方案(Digital Capture Solution),数字输出解决方案(Output Solution)以及数字乳腺放射成像解决方案,牙科及分子成像系统,各种数字和传统X光胶片产品在内的多个领域中,Carestream Health公司凭借丰富的整合方案以及专业全面的服务体系已经成为医疗数字成像市场的领导者。

Carestream Health公司在中国成立了锐珂(上海)医疗器材有限公司和锐珂(厦门)医疗器材有限公司,2009年又成立了锐珂亚太投资管理(上海)有限公司。依托柯达品牌百年来所积累的宝贵经验,通过充满激情、以客户为中心的团队,将不断追求技术发展和创新,为客户提供最新的医疗解决方案与技术,帮助从最小的诊所到***的医院等各个医疗机构实现长期彻底的投资回报和应用保障。

     中国区总部设在上海
     设立了17个办事处
     1个研发中心
     1个技术创新中心
     2个工厂,其中上海工厂主要用于医疗设备生产,厦门工厂主要用于医用胶片生产
     员工约1400名

    创新而又成功的丰厚历史,以及优秀的企业文化和巨大的发展机遇,使您在锐珂医疗的工作令人兴奋和喜悦。同时我们把员工看作是最宝贵的财富,一经录用,我们将提供极具竞争力的薪酬福利待遇和职业发展培训:

     具有行业竞争力的薪金
     社会保险及商业保险
     带薪年休假及全薪病假
     年度旅游及员工俱乐部
     节假日福利
     针对个人职业发展的培训

    请访问公司网页: www.carestream.com 获取更多公司信息。

Carestream Health was found in 2007 by Onex, as an independent subsidiary of Onex Corporation of Toronto. Onex acquired the Health Group of Eastman Kodak Company in a multi-billion-dollar transaction. As an independent subsidiary of Onex Corporation of Toronto, Carestream Health recorded 2011 revenues of almost $2.5 billion.

There are more than 8,100 employees all of the world and Carestream Health owns more than 1,000 patents for technology and intellectual property. Our products and services are present in 90% of hospitals worldwide. Depending on the abundant integrated plans and professional service system, we have become the leader of healthcare IT solutions market, including Carestream radiology solutions and information management solutions (RIS-PACS, IMS, EIM), CR, DR, CAD (computer aided detection) systems, laser imagers, services, mammography and oncology solutions, and a range of digital and traditional film-based dental products.

Carestream Health established Rayco (Shanghai) Medical Products Company Limited and Rayco (Xiamen) Medical Products Company Limited in China and established Rayco Asia Pacific Investment & Management (Shanghai) Company Limited in 2009. Relying on the centenary experiences accumulated by Kodak, through customer-oriented team with full enthusiasm, we always seek further technical developments and innovations, and supply our best solutions and techniques to help both clinics and hospitals achieve their long investment returns and applied services.

        *China headquarter is at Shanghai
        *17 offices all around China
        *One Global R&D Center at Shanghai
        *One Asia Technology & Innovation Center at Shanghai
        *Two factories in China, one is at Shanghai for medical equipment, the other is at Xiamen for medical film
        *Nearly 1,400 employees in China

        With the creative and successful history, the good company culture and great opportunities. It will be excited and cheerful to work at Carestream Health. The employee is the most valuable wealth for us, if hired, we will offer you competitive compensation and benefits:

        *Competitive Salary
        *Social & Business Insurance
        *Annual Leave & Sick Leave(full pay)
        *Outing & Staff Club
        *Festival Benefits
        *Personal Training Opportunities

        For more information, PLS visit: www.carestream.com

联系方式

  • 公司地址:地址:span新金桥路27号金桥软件园4号楼