醫(yī)藥法規(guī)專員
面議
五險
有年假
雙休
公積金
長白班
工作性質(zhì)全職
職位類別醫(yī)療設(shè)備注冊/醫(yī)療設(shè)備生產(chǎn)/醫(yī)療設(shè)備質(zhì)量管理
招聘人數(shù)1人
學歷要求本科
工作經(jīng)驗5年以上
性別要求不限
用工形式不限
技能等級不限
年齡要求不限
試用期一個月
試用期薪資面議
工作地點丹陽市/司徒鎮(zhèn)/司徒鎮(zhèn)
職位描述
Job responsibilities
工作職責
1.To be responsible for the registration and declaration of Medicine products , to independently compile medicine registration documents, to examine, organize and submit registration materials.負責國外藥品產(chǎn)品的注冊申報，獨立編寫藥品注冊文件，審核，整理及遞交注冊材料。
2.To master and follow up the changes of medicine registration regulations and quality regulations, analyze, summarize, organize and report to the quality manager in time to assist the implementation of the new regulations in the factory.掌握和跟蹤國外藥品注冊法規(guī)和質(zhì)量法規(guī)的變化，及時分析，歸納，整理，并匯報質(zhì)量經(jīng)理，協(xié)助新法規(guī)工廠內(nèi)的落實。
3.Responsible for handling matters encountered in the registration and quality certification of related products such as the competent government or institutions.負責處理各主管政府或者機構(gòu)等相關(guān)產(chǎn)品注冊，質(zhì)量認證中遇到的事務(wù)。
4.Responsible for the relevant inspection, testing and follow-up progress during the medicine registration process, such as type test, biocompatibility test, verification test, etc.負責藥品注冊過程中的相關(guān)檢驗，測試并跟進進度，例如型式實驗，生物相容性測試，包裝運輸驗證測試等。
5.Responsible for communicating with other relevant departments during registration process, taking the lead in solving some problems and assigning project implementation.負責注冊過程中與其他相關(guān)部門的溝通，牽頭解決一些問題并分派項目實施。
6.Assist the quality manager to build and improve the internal quality management system and participate in the internal and external audit of the quality management system.協(xié)助質(zhì)量經(jīng)理進行公司內(nèi)部質(zhì)量管理體系的建設(shè)和完善，參與質(zhì)量管理體系的內(nèi)審和外審工作。
7.Complete other related work assigned by company leader.完成公司領(lǐng)導分配的其他相關(guān)工作。
Job requirements
崗位要求
1.Bachelor degree or above in medicine, biology, materials, medical devices, etc., at least one year's experience in medicine registration.醫(yī)學類，生物類，材料類，醫(yī)療器械類等相關(guān)專業(yè)本科及以上學歷，至少一年醫(yī)藥類注冊工作經(jīng)驗。
2.To be familiar with the domestic and international medicine and other related laws and regulations and registration declaration, familiar with CE/FDA registration and other guiding principles ,510 K registration experience is preferred.熟悉國際醫(yī)藥等相關(guān)法律法規(guī)及注冊申報事宜，熟悉CE/FDA 注冊等各項指導原則，有510K 注冊經(jīng)驗尤佳。
工作職責
1.To be responsible for the registration and declaration of Medicine products , to independently compile medicine registration documents, to examine, organize and submit registration materials.負責國外藥品產(chǎn)品的注冊申報，獨立編寫藥品注冊文件，審核，整理及遞交注冊材料。
2.To master and follow up the changes of medicine registration regulations and quality regulations, analyze, summarize, organize and report to the quality manager in time to assist the implementation of the new regulations in the factory.掌握和跟蹤國外藥品注冊法規(guī)和質(zhì)量法規(guī)的變化，及時分析，歸納，整理，并匯報質(zhì)量經(jīng)理，協(xié)助新法規(guī)工廠內(nèi)的落實。
3.Responsible for handling matters encountered in the registration and quality certification of related products such as the competent government or institutions.負責處理各主管政府或者機構(gòu)等相關(guān)產(chǎn)品注冊，質(zhì)量認證中遇到的事務(wù)。
4.Responsible for the relevant inspection, testing and follow-up progress during the medicine registration process, such as type test, biocompatibility test, verification test, etc.負責藥品注冊過程中的相關(guān)檢驗，測試并跟進進度，例如型式實驗，生物相容性測試，包裝運輸驗證測試等。
5.Responsible for communicating with other relevant departments during registration process, taking the lead in solving some problems and assigning project implementation.負責注冊過程中與其他相關(guān)部門的溝通，牽頭解決一些問題并分派項目實施。
6.Assist the quality manager to build and improve the internal quality management system and participate in the internal and external audit of the quality management system.協(xié)助質(zhì)量經(jīng)理進行公司內(nèi)部質(zhì)量管理體系的建設(shè)和完善，參與質(zhì)量管理體系的內(nèi)審和外審工作。
7.Complete other related work assigned by company leader.完成公司領(lǐng)導分配的其他相關(guān)工作。
Job requirements
崗位要求
1.Bachelor degree or above in medicine, biology, materials, medical devices, etc., at least one year's experience in medicine registration.醫(yī)學類，生物類，材料類，醫(yī)療器械類等相關(guān)專業(yè)本科及以上學歷，至少一年醫(yī)藥類注冊工作經(jīng)驗。
2.To be familiar with the domestic and international medicine and other related laws and regulations and registration declaration, familiar with CE/FDA registration and other guiding principles ,510 K registration experience is preferred.熟悉國際醫(yī)藥等相關(guān)法律法規(guī)及注冊申報事宜，熟悉CE/FDA 注冊等各項指導原則，有510K 注冊經(jīng)驗尤佳。
