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醫(yī)療器械注冊專員

南京智服醫(yī)療器械咨詢服務有限公司...

南京

3-4年
本科
12-28 發(fā)布

職位信息

職位名稱：醫(yī)療器械注冊專員

類別名稱：

職位描述：

職位職能:醫(yī)療器械注冊崗位職責：1. 負責境外醫(yī)療器械產(chǎn)品注冊的統(tǒng)籌、協(xié)助完成境外醫(yī)療器械的立項調(diào)研、評估工作。2.根據(jù)中國法規(guī)要求，起草注冊產(chǎn)品標準。3.負責醫(yī)療器械的注冊申請，包括新產(chǎn)品的注冊申請、再注冊和補充申請。確保上述注冊申請符合國家的相關法規(guī)要求，并在公司規(guī)定的時限內(nèi)完成。4.負責注冊申請的前期準備工作，包括及時獲取注冊申請資料及樣品；進行注冊申請資料的翻譯、校對及編寫整理；協(xié)助注冊經(jīng)理完成注冊申請計劃的制訂。5. 及時匯總、分類、整理、歸檔國家藥品監(jiān)督管理部門出臺的各項法規(guī)、文件、技術(shù)資料。6. 接聽公司內(nèi)部及外部的咨詢電話任職要求：1、本科以上學歷，醫(yī)學或生物學相關專業(yè)；2、較強的協(xié)調(diào)和溝通能力；3、兩年以上醫(yī)療器械注冊經(jīng)驗；4、細心，并能及時有效的完成多種工作任務，5、團隊合作者6、語言要求：英語CET6以上，熟練掌握聽、說、讀、寫；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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