长沙招聘

PART I - POSITION SUMMARY 职位概要

Sr. Regulatory Compliance Specialist is responsible to ensure regulatory compliance of Teleflex product importing, operation and labeling in China.

PART II - PRINCIPAL RESPONSIBILITIES 主要职责

1. Draft Chinese Instruction for Use and label according to the information of registration, assist in compiling regulatory filing documents and maintaining computerized files to support RA documentation systems;

2. Updates Teleflex databases and catalogues of regulatory compliance information, such as Kingdee system, SLC database etc., coordinates the review and revision of procedures, specifications and forms;

3. Set RA SOP to ensure regulatory compliance, keeps abreast of regulatory procedures and changes;

4. Provide regulatory support to related function (QA, DP, Supply chain and local BU), recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance;

5. Coordinates the preparation of and may prepare document packages for all areas of company as well as for internal and external audits and inspections;

6. Provide supporting documents to MA for product tendering/biding in China;

7. Performs evaluation of internal operations, controls, communications, risk assessments and maintenance of documentation as related to regulatory compliance and recommends appropriate changes;

8. Provide RA NEO training to new hire and help them to familiar with Teleflex RA SOP;

9. Schedule, plan and organize internal workshop with CFDA CMDE and CFDA test centers;

10.Provide RA info to SLC to ensure regulatory compliance of Chinese label release;

PART III – QUALIFICATIONS 任职要求

EDUCATION 教育程度

Bachelor degree or above, major in Medical, Medical device, Biomedical Engineering etc.

EXPERIENCE 工作经验

1. Related working experience for above 2 years in medical device industry;

2. Strategic thinking and project management;

3. Proficient in the use of MS office software, especially Excel and Word.

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

1. Proficiency communication in Chinese and English

2. Good Planning & coordinating skill, experience and ability in problem solving independently

3. Carefulness, preciseness, initiative and strong rationality, strong sense of responsibility and team work

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