北京相关职位： 科研助理 销售代表-CC 临床协调员(CRC) 临床试验项目经理 分子生物与细胞生物学实验员 客户服务部产品培训专员（北京） 临床学术支持(职位编号：002) 质量体系专员(职位编号：ganlee002062) 质量合规经理(职位编号：ganlee002053) 临床监察员(职位编号：2018L001)
周边城市招聘： 上海 浙江 安徽 广东 山东 河北 重庆 北京 江苏 湖南
企业入驻日期： 2017-11-09
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5-7年经验 -
本科 -
招1人 -
03-04 发布
- 五险一金
- 补充医疗保险
- 补充公积金
- 交通补贴
- 餐饮补贴
- 通讯补贴
- 年终奖金
- 定期体检
职位描述
Prepare for pre-market approval, set up regulatory strategy for new product launch, update and maintain CFDA license, establish and maintain relationship with regulatory authorities and KOLs, provide regulatory support to internal team. Lead a working group (specific BU, 2-3 members) on China pre-market approval and ensure regulatory compliance of specific product line. Communicate with BU RA (overseas facilities) and Set the reasonable regulatory strategy for new product launch. Update and maintain valid CFDA license under China regulationEstablish and implement plans to maintain a trusted relationship with the local regulatory authorities and related KOL (testing center, National standard committee and so on)Provide regulatory support to BU and related functions (tender/biding , QA, DC and so onRelevant RA experiences for more than 5 years. Working experience in international company is preferred.Self-motivated and strategic thinkingStrong communication skill in Chinese and English 职能类别： 医疗器械注册 关键字： 医疗耗材注册
联系方式
北京市朝阳区颐堤港
公司信息
美国泰利福： 成立于1943年的美国泰利福是一家在重症监护和外科领域处于领先地位的跨国企业， 全球有超过11000名员工，年销售额为17亿美金。 泰利福为全球150多个国家的医疗机构提供高品质多种类的产品组合， 目前共有血管通路Vascular Access、外科Surgical、泌尿Urology、心脏辅助CA、麻醉呼吸Anesthesia & Respiratory、专业产品OEM和其他产品六条产品线。我们在全球25个国家建立销售公司和生产基地，并且在美国、马来西亚、捷克和德国建有研发中心。 泰利福中国： 泰利福在中国的业务已超过20年之久： 90年代初，泰利福以Pilling 品牌进入中国市场； 1996年，泰利福就在北京设立了代表处，开始进入中国市场； 2007年，我们在上海成立了第一家独资企业-泰利福医疗器械商贸(上海)有限公司，标志着泰利福中国进入另一个里程碑发展阶段。 长久以来， 泰利福一直致力于在血管通路Vascular Access、外科Surgical、泌尿Urology、心脏辅助CA、麻醉呼吸Anesthesia & Respiratory和专业产品OEM和其他产品领域向中国的客户提供安全可靠的医疗耗材产品。 我们的一些知名的品牌包括Arrow、 Deknatel、 Hudson RCI、 KMedic、 Pilling、 Pleur-Evac、 Rusch、 TAUT 和Weck。 随着公司在中国的业务扩大，我们期待更多的专业人士加入我们的团队。 愿景： 成为一次性重症监护产品及外科产品领域的国际领先公司 使命： 通过提供微创、降低感染及高安全性的产品改善临床疗效 了解更多信息，敬请关注泰利福官方网站(英文网站） www.teleflexmedical.com 或 泰利福中国专属招聘门户网站（中文网站） teleflex.zhiye.com Teleflex Incorporated: Founded in 1943, Teleflex is a global provider of medical devices used in critical care and surgery, with sales revenue of 1.7 billion USD. We have more than 11,000 employees worldwide. We serve healthcare providers in more than 150 countries with specialty devices for Vascular Access, Surgical, Urology, CA, Anesthesia & Respiratory、OEM and others. We have sales operations & manufacture in 25 countries, and set up R&D Centers in U.S., Malaysia, Czech Republic and Germany. Teleflex China: Teleflex China also has a reputation for excellence that spans over 20 years in China. Back to 1996, we founded our first representative office in Beijing. In 2007, we founded our WOFE, Teleflex Medical Trading Shanghai Company Limited in Shanghai, a milestone in the development of Teleflex business in China. For years, we provide disposable medical consumables in surgical, critical care, CA, Anesthesia and Respiratory, and Urology to our Chinese customers. As our business is growing tremendously in China market, now we are looking for more professionals to join us. Vision Statement Create a world leader in disposable medical products for critical care and surgical applications. Mission Statement To enhance patient outcomes by providing products that are less invasive, reduce infections, and improve patient safety. For more information, please visit our website: www.teleflexmedical.com and our recruitment portal: teleflex.zhiye.com
