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行業(yè)：知名美資醫(yī)療器械
中智合同一年for變更項(xiàng)目，續(xù)約視人員表現(xiàn)及項(xiàng)目情況，投遞前請知悉
薪資健全：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;
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)管知識和科學(xué)知識的堅(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；