长沙招聘

PART I - POSITION SUMMARY 职位概要


Develop and execute plan to get products registered for sales in China and to ensure product distribution and sales in China are in compliant with Chinese laws and regulations, as well as Teleflex company’s rules and requirements.



PART II - PRINCIPAL RESPONSIBILITIES 主要职责


1. To develop product registration plans and budget of the RA/QA Department.

2. To be responsible for the planning and execution of annual objectives; monitor and improve

progress.

3. To manage the RA team to meet business needs and support consistent business growth in

regulatory affairs and quality affairs areas.

4. To build a strong and professional team in technical knowledge and communication skills.

5. To develop high levels of credibility and forge solid and positive professional

relationships with government authorities, manufacturers, other departments and senior

management of the company.

6. Manage the importation and local testing of product samples according relevant

international, national and specific product standards

7. Prepare dossiers for submission to SFDA and manage their review through to approval

8. Actively participate in industry networks and conferences to maintain knowledge of current

regulations and have influence over/ input into the development of new/ amendment of

existing regulations.

9. Compliant to Teleflex Code of conduct and other corporate policies. Adherent to applicable

local laws and industry code of ethics including but not limited to FCPA, AdvaMed Code of

Ethics. Do the right things and do things right.



PART III – QUALIFICATIONS 任职要求

EDUCATION 教育程度



B.S. degree or the equivalent with clinical medicine, Medical Device, biomedicine engineer, material.


EXPERIENCE 工作经验

Tertiary qualifications in relevant discipline: Science , Medicine, Engineering or other
Approximately 6 years work experience in medical device regulatory affairs in China
Expert knowledge of the Medical Device regulations (relevant statutes and practices)
Familiar with quality management system.



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

People management experience
Excellent project management skills
Excellent verbal and written communication in Mandarin and English languages

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