行業：外資醫療器械 職位：RA 工作地點：朝陽區建國路79號華貿中心2號寫字樓 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作，確保注冊文件質量及按時完成； 維持現有產品許可證并確保標簽符合法規要求； 主動與檢測實驗室、CMDE等外部機構聯系，加快注冊進程； 為上市后提供監管支持，并根據需要采取相應的監管行動以保持合規性，為跨部門提供所需的監管支持； 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; 藥學相關專業本科及以上學歷； 具有制藥公司至少2年工作經驗，優先考慮RA部門、MA部門或其他技術職能； 監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； （簽中智合同，福利健全：五險一金、補充商業保險、13薪、年節福利、法定及福利年假）