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(jìn)口醫(yī)療器械產(chǎn)品注冊(cè)的相關(guān)工作（涉及注冊(cè)產(chǎn)品標(biāo)準(zhǔn)、產(chǎn)品檢測(cè)、產(chǎn)品注冊(cè)資料的準(zhǔn)備及整理），確保產(chǎn)品申報(bào)的進(jìn)度。



PART II - PRINCIPAL RESPONSIBILITIES 主要職責(zé)

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(jīng)理或其他人的幫助下，負(fù)責(zé)公司醫(yī)療器械產(chǎn)品在國(guó)內(nèi)的注冊(cè)，確保產(chǎn)品的注冊(cè)進(jìn)程按照計(jì)劃進(jìn)行, 包括：

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

與市場(chǎng)部，銷售部，國(guó)際注冊(cè)部進(jìn)行協(xié)調(diào)，制定注冊(cè)計(jì)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(guān)法律法規(guī)及標(biāo)準(zhǔn)的要求，起草產(chǎn)品技術(shù)要求(根據(jù)產(chǎn)品)，跟進(jìn)產(chǎn)品檢測(cè)；與檢驗(yàn)、測(cè)試機(jī)構(gòu)保持密切聯(lián)系，建立良好關(guān)系，確保注冊(cè)檢驗(yàn)的順利進(jìn)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(guó)家藥監(jiān)局等部門聯(lián)系溝通，確保各個(gè)注冊(cè)申請(qǐng)的報(bào)送、技術(shù)審評(píng)和審批的順利進(jìn)行，實(shí)時(shí)跟蹤產(chǎn)品注冊(cè)進(jìn)程，確保按時(shí)獲證

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

取得注冊(cè)證書后,如需要,根據(jù)實(shí)際情況,進(jìn)行注冊(cè)證書的變更、糾錯(cuò)、說(shuō)明書備案的工作

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

負(fù)責(zé)研究和了解國(guó)內(nèi)國(guó)際的法律法規(guī)，為產(chǎn)品注冊(cè)或認(rèn)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(chǎn)品的注冊(cè)資料文檔，負(fù)責(zé)產(chǎn)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(jīng)理或其他人的指導(dǎo)下，根據(jù)CFDA的要求，制作產(chǎn)品的中文標(biāo)簽和說(shuō)明書

5. Provide related document to Commercial, Sales department.

提供公司商務(wù)、銷售部門招投標(biāo)需要的有關(guān)法規(guī)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(xué)本科及以上學(xué)歷，醫(yī)學(xué)，醫(yī)療器械、生物醫(yī)學(xué)工程、機(jī)電、材料等專業(yè)優(yōu)先；



EXPERIENCE 工作經(jīng)驗(yàn)

1. At least 2 years experience in registration.

至少有2年產(chǎn)品注冊(cè)經(jīng)驗(yàn)。

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

熟悉國(guó)內(nèi)醫(yī)療器械產(chǎn)品注冊(cè)流程、行業(yè)法規(guī)規(guī)定及標(biāo)準(zhǔn)

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(fēng)細(xì)致、嚴(yán)謹(jǐn)、主動(dòng)、條理性強(qiáng)，有高度的責(zé)任感和良好的團(tuán)隊(duì)合作精神

美國(guó)泰利福：
成立于1943年的美國(guó)泰利福是一家在重癥監(jiān)護(hù)和外科領(lǐng)域處于領(lǐng)先地位的跨國(guó)企業(yè)， 全球有超過(guò)11000名員工，年銷售額為17億美金。

泰利福為全球150多個(gè)國(guó)家的醫(yī)療機(jī)構(gòu)提供高品質(zhì)多種類的產(chǎn)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(yè)產(chǎn)品OEM和其他產(chǎn)品六條產(chǎn)品線。我們?cè)谌?5個(gè)國(guó)家建立銷售公司和生產(chǎn)基地，并且在美國(guó)、馬來(lái)西亞、捷克和德國(guó)建有研發(fā)中心。

泰利福中國(guó)：
泰利福在中國(guó)的業(yè)務(wù)已超過(guò)20年之久： 90年代初，泰利福以Pilling 品牌進(jìn)入中國(guó)市場(chǎng)； 1996年，泰利福就在北京設(shè)立了代表處，開(kāi)始進(jìn)入中國(guó)市場(chǎng)； 2007年，我們?cè)谏虾３闪⒘说谝患要?dú)資企業(yè)-泰利福醫(yī)療器械商貿(mào)(上海)有限公司，標(biāo)志著泰利福中國(guó)進(jìn)入另一個(gè)里程碑發(fā)展階段。
長(zhǎng)久以來(lái)， 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(yè)產(chǎn)品OEM和其他產(chǎn)品領(lǐng)域向中國(guó)的客戶提供安全可靠的醫(yī)療耗材產(chǎn)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(guó)的業(yè)務(wù)擴(kuò)大，我們期待更多的專業(yè)人士加入我們的團(tuán)隊(duì)。

愿景：
成為一次性重癥監(jiān)護(hù)產(chǎn)品及外科產(chǎn)品領(lǐng)域的國(guó)際領(lǐng)先公司

使命：
通過(guò)提供微創(chuàng)、降低感染及高安全性的產(chǎn)品改善臨床療效

了解更多信息，敬請(qǐng)關(guān)注泰利福官方網(wǎng)站(英文網(wǎng)站） www.teleflexmedical.com 或 泰利福中國(guó)專屬招聘門戶網(wǎng)站（中文網(wǎng)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