北京招聘

JOB PURPOSE：

· PMS responsibilities including complaints handling, AE reporting and recall, focus on AE reporting and risk evaluation report finalize;

上市后监管职责，包括投诉处理，不良事件上报，召回。

· Prepare PRER and submit on time to ensure compliance;

准备定期风险评价报告并按时递交。

· Owner of PMS related SOP;

PMS相关流程的owner;

KEY RESPONSIBILITES：

· Responsible for AE reporting, interface and coordinator among sales, customers, complaints handling and NMPA; Drive to confirm the event and follow up the investigation progress, prepare the evaluation in the national AE monitoring system, monitor the progress in the system until approved by NMPA;

负责不良事件上报，作为销售、经销售以及医院、药监局的沟通窗口；推动进行不良事件确认，跟进调查进度并进行评价，跟进直至审核通过；

· Work with legal manufacturer to prepare the required risk evaluation reports, finalize and submit to NMPA on time;

与法定厂商合作，准备风险评价报告并按时递交；

· Oversight and escalate any major event received; Ensure all reports are in compliance with applicable regulations and policies;

对于严重不良事件及时向上层汇报，确认所有的不良事件上报均符合相关法规和政策要求；

· Analyze and report AE trends on monthly basis, identify new and/or systemic issues and escalate as necessary.

按月对不良事件进行统计分析，识别新问题或系统性问题；

· Owner of the PMS related SOP; Conduct related regulation and SOP training to staff;

PMS相关SOP 的owner, 对员工进行相关法规和SOP的培训；

· Support customer complaints handling as needed;

支持客户投诉处理；

· Support first distribution check including product master data and distributors license check;

支持首营审核，包括产品首营和购货者首营等；

· Other tasks assigned by line manager

其它上级主管分派的任务；

ESSENTIAL SKILLS / EXPERIENCE：

· A minimum of 3 years of experience in Quality department, medical device field is preferred.

· Experiences in AE reporting is a must, in recall and complaints handling is preferred.

· Demonstrated technical knowledge of appropriate ISO and NMPA medical device regulations and safety standards including ISO 13485 and GSP.

· Experience with SAP or Kingdee system is nice to have.

BEHAVIOURS / VALUES：

· Bachelor degree or above, major in engineering or medical device.

· Proactive and cooperative, team spirit

· Good communication skills in both English and Chinese

· Strong interpersonal and communication skills

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