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行業(yè)：知名美資醫(yī)療器械
中智合同一年for注冊變更項目，續(xù)約視人員表現(xiàn)及部門情況，投遞前請知悉
薪資健全：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(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；
主動與檢測實驗室、CMDE等外部機構(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，優(yōu)先考慮RA部門、MA部門或其他技術(shù)職能；
監(jiān)管知識和科學(xué)知識的堅實基礎(chǔ)；
良好的英語聽說讀寫能力；
良好的溝通和人際交往能力；