长沙招聘

PART I - POSITION SUMMARY 职位概要
1.Management of recall activities associated with Teleflex China recall / field action execution and reporting activities.
2.Responsible for reviewing and submitting the oversea MDR reports to CFDA
3.Ensure all the Chinese version label / IFU are in compliance with CFDA regulations

PART II - PRINCIPAL RESPONSIBILITIES 主要职责
1.Support and attend group meetings to review open recalls and ensure resources are delegated appropriately.
2.Ensure documentation (procedures, forms, etc.) is in place to clearly define required reporting activities and records for handling Teleflex Medical recalls.
3.Manage the Product Corrections and Removals process which includes responsibility for assembling product and customer data concerning product corrections, removals and field upgrades, tracking of Customer notifications and Field actions, and maintenance of correction documentation.
4.Ensure recall information is tracked / trended and communicated in order to provide manufacturing and Product Development with the necessary information to assess their own areas of responsibility relative to product quality.
5.Proofread the draft of Chinese version label and IFU, ensure the total compliance with CFDA regulations (i.e. No. 10 Order of CFDA)
6.Review and submit certain types of reports for adverse events and product problems (MDR) to the CFDA
7.He/she will continually assess internal department procedures and ensure they remain in compliance with applicable regulations and standards (i.e. No.276 Order of CFDA, and No. 469 Order of Shanghai CFDA)
8.Compile, monitor, and report on trending of pertinent RA/QA related metrics, as required.
9.Control access to, and maintain the organization of, the Quality & Regulatory Compliance document archive folder.

PART III – QUALIFICATIONS资质要求

EDUCATION教育程度

Bachelor degree

EXPERIENCE工作经验

?A minimum of 2 years of experience in an ISO regulated environment is required.
?Previous experience with the execution and/or reporting of recalls or field safety notices is required.
?Working knowledge of <Regulations for the Supervision and Administration of Medical Devices> No.276 Order of CFDA; <Provisions for the Instructions, Labels and Package of Medical Devices> No.10 Order of CFDA is required.

OTHER QUALIFICATIONS (Physical, Visual etc.)其他要求

?General knowledge of the requirements for medical devices and MDR, MPR, and Vigilance reporting is preferred.
?Knowledge and understanding of regulatory requirements relative to complaint handling is preferred.
?Strong team, interpersonal and communication (written, oral and listening) skills.
?Fluent English speaker and writer on working subjects.

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***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） ***********************

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: ***********************