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行業(yè)：外資，醫(yī)療器械 職位：RA 工作地點(diǎn)：朝陽區(qū)建國路79號(hào)華貿(mào)中心2號(hào)寫字樓 通過面試者，勞動(dòng)合同簽中智一年，薪資福利架構(gòu)：五險(xiǎn)一金、補(bǔ)充商業(yè)保險(xiǎn)、13薪、年節(jié)福利、法定及福利年假 Essential Duties and Responsibilities To manage medical device registration whole process from project kick-off to products launch, work with internal cross function closely to ensure the registration files quality and completion on time; To maintain existing product license and ensure labeling regulatory compliance; To actively contact with external parties such as testing lab, CMDE to accelerate the registration processes; To provide regulatory support for post-market and take regulatory actions accordingly to keep compliance, provide regulatory support for cross function as needed; 支持醫(yī)療器械注冊全周期管理，從項(xiàng)目啟動(dòng)到產(chǎn)品上市，與內(nèi)部跨部門緊密協(xié)作，確保注冊文件質(zhì)量及按時(shí)完成； 維持現(xiàn)有產(chǎn)品許可證并確保標(biāo)簽符合法規(guī)要求； 主動(dòng)與檢測實(shí)驗(yàn)室、CMDE等外部機(jī)構(gòu)聯(lián)系，加快注冊進(jìn)程； 為上市后提供監(jiān)管支持，并根據(jù)需要采取相應(yīng)的監(jiān)管行動(dòng)以保持合規(guī)性，為跨部門提供所需的監(jiān)管支持； Qualifications: Bachelor’s degree or above in Pharmaceutical related discipline; With minimum of 2 years’ work experience of pharmaceutical companies, prefer in RA dept, MA dept or other technical functions; Sound basis of Regulatory knowledge and Scientific Knowledge; Good English skill, both oral and written; Excellent communication and interpersonal skills; 藥學(xué)相關(guān)專業(yè)本科及以上學(xué)歷； 具有制藥公司至少2年工作經(jīng)驗(yàn)，優(yōu)先考慮RA部門、MA部門或其他技術(shù)職能； 監(jiān)管知識(shí)和科學(xué)知識(shí)的堅(jiān)實(shí)基礎(chǔ)； 良好的英語聽說讀寫能力； 良好的溝通和人際交往能力；