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行業(yè)：外資，醫(yī)療器械 職位：RA 工作地點：朝陽區(qū)建國路79號華貿中心2號寫字樓 通過面試者，勞動合同簽中智一年，薪資福利架構：五險一金、補充商業(yè)保險、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，從項目啟動到產品上市，與內部跨部門緊密協(xié)作，確保注冊文件質量及按時完成； 維持現(xiàn)有產品許可證并確保標簽符合法規(guī)要求； 主動與檢測實驗室、CMDE等外部機構聯(lián)系，加快注冊進程； 為上市后提供監(jiān)管支持，并根據需要采取相應的監(jiān)管行動以保持合規(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; 藥學相關專業(yè)本科及以上學歷； 具有制藥公司至少2年工作經驗，優(yōu)先考慮RA部門、MA部門或其他技術職能； 監(jiān)管知識和科學知識的堅實基礎； 良好的英語聽說讀寫能力； 良好的溝通和人際交往能力；