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醫(yī)療器械注冊(cè)專(zhuān)員

南京智服醫(yī)療器械咨詢(xún)服務(wù)有限公司...

南京

  • 工作年限3-4年
  • 學(xué)歷要求本科
  • 招聘人數(shù)
  • 發(fā)布日期12-28 發(fā)布
  • 語(yǔ)言要求
職位信息

職位名稱(chēng)： 醫(yī)療器械注冊(cè)專(zhuān)員

類(lèi)別名稱(chēng)：

職位描述：
職位職能:醫(yī)療器械注冊(cè)崗位職責(zé)：1. 負(fù)責(zé)境外醫(yī)療器械產(chǎn)品注冊(cè)的統(tǒng)籌、協(xié)助完成境外醫(yī)療器械的立項(xiàng)調(diào)研、評(píng)估工作。2.根據(jù)中國(guó)法規(guī)要求，起草注冊(cè)產(chǎn)品標(biāo)準(zhǔn)。3.負(fù)責(zé)醫(yī)療器械的注冊(cè)申請(qǐng)，包括新產(chǎn)品的注冊(cè)申請(qǐng)、再注冊(cè)和補(bǔ)充申請(qǐng)。確保上述注冊(cè)申請(qǐng)符合國(guó)家的相關(guān)法規(guī)要求，并在公司規(guī)定的時(shí)限內(nèi)完成。4.負(fù)責(zé)注冊(cè)申請(qǐng)的前期準(zhǔn)備工作，包括及時(shí)獲取注冊(cè)申請(qǐng)資料及樣品；進(jìn)行注冊(cè)申請(qǐng)資料的翻譯、校對(duì)及編寫(xiě)整理；協(xié)助注冊(cè)經(jīng)理完成注冊(cè)申請(qǐng)計(jì)劃的制訂。5. 及時(shí)匯總、分類(lèi)、整理、歸檔國(guó)家藥品監(jiān)督管理部門(mén)出臺(tái)的各項(xiàng)法規(guī)、文件、技術(shù)資料。6. 接聽(tīng)公司內(nèi)部及外部的咨詢(xún)電話(huà)任職要求：1、本科以上學(xué)歷，醫(yī)學(xué)或生物學(xué)相關(guān)專(zhuān)業(yè)；2、較強(qiáng)的協(xié)調(diào)和溝通能力；3、兩年以上醫(yī)療器械注冊(cè)經(jīng)驗(yàn)；4、細(xì)心，并能及時(shí)有效的完成多種工作任務(wù)，5、團(tuán)隊(duì)合作者6、語(yǔ)言要求：英語(yǔ)CET6以上，熟練掌握聽(tīng)、說(shuō)、讀、寫(xiě)；Office Admin/Regulatory Assistant for Medical Devices – ChinaWe are seeking for an office assistant, who will take charge of the day to day running of the office and all administrative tasks. Additional duty is to coordinate and facilitate manager with medical device regulatory submissions and international registrations for new products.This is a challenging position for people with passion and learning desire. Opportunity to be promoted as junior regulatory consultant is open.Activities1.Maintain the daily administrative operation for a small but dynamic office2.Support to prepare CFDA dossier (arrangement/file/archive) for medical device registration in accordance with CFDA requirements in timely manner, and support registration manager to complete all procedures.3.Coordinating the collection and transfer of technical data internally to support submissions.4.Maintaining good communication with internal and external stakeholders to ensure timely service delivery.5.Keep updated of CFDA regulatory knowledge.6.Answering phone calls and emailsRequirements1.Bachelor degree or above, chemistry, medicine or biology major desired2.Excellent communication and coordination skills3.Preferablly 2 years’ experience working in regulatory submission or quality control in Medical Devices industry, with sufficient CFDA regulatory knowledge4.Detailed oriented and ability to document effectively and completely.5.Proactive attitude6.Multiple-task management ability7.Team player8.Excellent command of English language, CET 6 aboveThe position is based in downtown area Nanjing, convenient transportation with bus and metro.
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電信與信息服務(wù)業(yè)務(wù)經(jīng)營(yíng)許可證編號(hào):京ICP證140722號(hào) 藥品醫(yī)療器械網(wǎng)絡(luò)信息服務(wù)備案(京)網(wǎng)藥械信息備字(2023)第00464號(hào)網(wǎng)絡(luò)備案:京ICP備12039121號(hào)-1
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