職位描述
職位描述：
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(xiāo)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(mén)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(shū)后,如需要,根據(jù)實(shí)際情況,進(jìn)行注冊(cè)證書(shū)的變更、糾錯(cuò)、說(shuō)明書(shū)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(xún)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(shū)
5. Provide related document to Commercial, Sales department.
提供公司商務(wù)、銷(xiāo)售部門(mén)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(zhuān)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
