PART I - POSITION SUMMARY 職位概要

Mainly engaged in registration for imported medical devices (including registration product standards, product inspection, register data preparation and filing), to make sure the progress of application.

主要從事進口醫療器械產品注冊的相關工作（涉及注冊產品標準、產品檢測、產品注冊資料的準備及整理），確保產品申報的進度。



PART II - PRINCIPAL RESPONSIBILITIES 主要職責

1. With manager or other people’s help, be responsible for the local registration of medical device products, to ensure registration is processed as plan, including:

在經理或其他人的幫助下，負責公司醫療器械產品在國內的注冊，確保產品的注冊進程按照計劃進行, 包括：

（1） Coordinate with Marketing, Sales and Global RA, to work out registration plan.

與市場部，銷售部，國際注冊部進行協調，制定注冊計劃

（2）According to the relevant regulations and standard requirements, draft the product technical requirements（depends on product), follow up product test. Keep in touch with the test institutions closely with a good relationship. Ensure test can be proceeded smoothly.

按照相關法律法規及標準的要求，起草產品技術要求(根據產品)，跟進產品檢測；與檢驗、測試機構保持密切聯系，建立良好關系，確保注冊檢驗的順利進行

（3）Communication with CFDA, to ensure submission, technical review and administrative approval to proceed smoothly in each application. Tracking product registration process to make sure the certification getting on time.

與國家藥監局等部門聯系溝通，確保各個注冊申請的報送、技術審評和審批的順利進行，實時跟蹤產品注冊進程，確保按時獲證

（4）To make necessary change, correction, IFU-Updating after getting the registration certificate.

取得注冊證書后,如需要,根據實際情況,進行注冊證書的變更、糾錯、說明書備案的工作

2. Study and understand local/international regulation, provide basic suggestion on registration or certification.

負責研究和了解國內國際的法律法規，為產品注冊或認證提供基本的咨詢建議

3. Maintain registration documents in order, file the product data.

有序管理產品的注冊資料文檔，負責產品的資料歸檔

4. To make the Chinese label and IFU according to CFDA’s requirements with manager or other people’s guide

在經理或其他人的指導下，根據CFDA的要求，制作產品的中文標簽和說明書

5. Provide related document to Commercial, Sales department.

提供公司商務、銷售部門招投標需要的有關法規文件。



PART III – QUALIFICATIONS 任職要求

EDUCATION 教育程度

Bachelor degree or above, major in Medical, Medical device, Biomedical Engineering, Electro-mechanics, Materials is preferred

大學本科及以上學歷，醫學，醫療器械、生物醫學工程、機電、材料等專業優先；



EXPERIENCE 工作經驗

1. At least 2 years experience in registration.

至少有2年產品注冊經驗。

2. Familiar with local medical device registration process, regulations and standards.

熟悉國內醫療器械產品注冊流程、行業法規規定及標準

3. Proficient in the use of MS Office suite.

能夠熟練操作常用辦公軟件。



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

1. common communication in Chinese and English

有通常水平的中英文溝通能力

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

工作作風細致、嚴謹、主動、條理性強，有高度的責任感和良好的團隊合作精神

美國泰利福：
成立于1943年的美國泰利福是一家在重癥監護和外科領域處于領先地位的跨國企業， 全球有超過11000名員工，年銷售額為17億美金。

泰利福為全球150多個國家的醫療機構提供高品質多種類的產品組合， 目前共有血管通路Vascular Access、外科Surgical、泌尿Urology、心臟輔助CA、麻醉呼吸Anesthesia & Respiratory、專業產品OEM和其他產品六條產品線。我們在全球25個國家建立銷售公司和生產基地，并且在美國、馬來西亞、捷克和德國建有研發中心。

泰利福中國：
泰利福在中國的業務已超過20年之久： 90年代初，泰利福以Pilling 品牌進入中國市場； 1996年，泰利福就在北京設立了代表處，開始進入中國市場； 2007年，我們在上海成立了第一家獨資企業-泰利福醫療器械商貿(上海)有限公司，標志著泰利福中國進入另一個里程碑發展階段。
長久以來， 泰利福一直致力于在血管通路Vascular Access、外科Surgical、泌尿Urology、心臟輔助CA、麻醉呼吸Anesthesia & Respiratory和專業產品OEM和其他產品領域向中國的客戶提供安全可靠的醫療耗材產品。 我們的一些知名的品牌包括Arrow、 Deknatel、 Hudson RCI、 KMedic、 Pilling、 Pleur-Evac、 Rusch、 TAUT 和Weck。
隨著公司在中國的業務擴大，我們期待更多的專業人士加入我們的團隊。

愿景：
成為一次性重癥監護產品及外科產品領域的國際領先公司

使命：
通過提供微創、降低感染及高安全性的產品改善臨床療效

了解更多信息，敬請關注泰利福官方網站(英文網站） www.teleflexmedical.com 或 泰利福中國專屬招聘門戶網站（中文網站） 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