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1. Principal Duties and Responsibilities (General Summary , essential functions and authorities, etc.) 主要工作職責(zé)（基本概況，主要功能，權(quán)限等） I. NMPA paper document submission and approval letter collection, including Class I filing and IFU filing. NMPA紙質(zhì)文件遞交和批件領(lǐng)取，包括一類備案和IFU備案等。 II. Consultation appointment of NMPA before product registration acceptance. 產(chǎn)品注冊(cè)受理前NMPA的咨詢預(yù)約。 III. Fees for registration items, including registration fee, test fee and translation fee. 注冊(cè)項(xiàng)目繳費(fèi)，包括注冊(cè)費(fèi)、檢測(cè)費(fèi)、翻譯費(fèi)等。 IV. Management of electronic medical device registration certificate, including download, archiving and release. 醫(yī)療器械電子注冊(cè)證的管理，包括下載、存檔和發(fā)布。 V. Tracking and Statistics of Regulatory Submission and Approval Information. 注冊(cè)遞交和批準(zhǔn)信息的追蹤和統(tǒng)計(jì)。 VI. Lifecycle Archiving of Product Registration Application Dossiers. 產(chǎn)品注冊(cè)申報(bào)資料生命周期存檔。 VII. Internal and external account authority management, including NMPA government platform, testing institute, internal system, etc. 內(nèi)部和外部賬戶權(quán)限管理，包括NMPA政務(wù)平臺(tái)、檢測(cè)所、內(nèi)部系統(tǒng)等。 VIII. Responsible for collecting CGUDID data and comprehensively understanding relevant regulatory policies and processes. 收集CGUDID數(shù)據(jù)，并全面了解法規(guī)政策和流程。 IX. Honghui system daily maintenance and data entry check. 紅會(huì)系統(tǒng)日常維護(hù)和數(shù)據(jù)錄入檢查。 X. Fully understand the management of relevant Certificates of the Company, and the archive path. 充分了解對(duì)公司相關(guān)證照及存檔路徑的管理。 XI. Post Market Compliance: maintain related database accurately; execute routine after-approval processes e.g. Chinese labeling, copy review etc.; timely assess change notification of LCM products, trigger necessary registration activities immediately; support post market actions e.g. audit, inspection, recall…be sensitive on potential regulatory risks. 上市后合規(guī)：準(zhǔn)確維護(hù)相關(guān)數(shù)據(jù)庫；執(zhí)行例行的批準(zhǔn)后流程，例如貼中文標(biāo)簽、文案審查等；及時(shí)評(píng)估LCM產(chǎn)品的變更通知，立即觸發(fā)必要的注冊(cè)活動(dòng)；支持上市后舉措，例如審核、檢驗(yàn)、召回……對(duì)潛在的監(jiān)管風(fēng)險(xiǎn)保持敏感。 XII. Actively assist in optimizing process operations and the execution of the actions in need. Track and complete the operation of the QMS process as it relates to RA, including JD, SOP/WI. Establish the basic acknowledgement of the QMS and think about the improvements. Find out the pain points in each process documents and share ideas with relevant colleges. 在需要時(shí)積極協(xié)助優(yōu)化流程操作和執(zhí)行需要采取的措施。跟蹤并完成與法規(guī)事務(wù)（RA）相關(guān)的質(zhì)量管理體系（QMS）流程的操作，包括職位說明（JD）、標(biāo)準(zhǔn)操作程序（SOP）/作業(yè)指導(dǎo)書（WI）。制定QMS的基礎(chǔ)知識(shí)并思考相關(guān)改進(jìn)。 找出每個(gè)流程文件中的痛點(diǎn)，并與相關(guān)同事分享想法。 XIII. Actively support and cooperate the internal and external audit, helping with unexpected issues and problems. 積極支持和配合內(nèi)部和外部審核工作，幫助解決突發(fā)問題。 XIV. Process Excellence: follow company SOP/WI/guidance on routine processes; actively think about improvement & speak out ideas. 流程優(yōu)化：遵循公司標(biāo)準(zhǔn)操作程序（SOP）/作業(yè)指導(dǎo)書（WI）/常規(guī)流程指南；積極思考改進(jìn)并提供思路。 XV. Policy shaping: Curiosity and passion for new regulation, policy, standards and technologies; be familiar with NMPA/CMDE/Lab common working processes; correctly interpret key regulatory requirements by self learning or participating training, preliminarily reflect on impact & implication to projects/business; train WWBU RA & other function members. 政策思維塑造：對(duì)新法規(guī)、政策、標(biāo)準(zhǔn)和技術(shù)懷有好奇心和熱情；熟悉NMPA/CMDE/實(shí)驗(yàn)室常見工作流程；通過自學(xué)或參與培訓(xùn)正確解讀關(guān)鍵注冊(cè)要求，初步反思對(duì)項(xiàng)目/業(yè)務(wù)的影響和啟示；培訓(xùn)全球業(yè)務(wù)部門法規(guī)事務(wù)部和其他職能部門成員。 XVI. Responsible for daily external Disclosure of Product Common and Confidential Documents and archive the relevant information; think about the main reasons affecting work efficiency. 負(fù)責(zé)產(chǎn)品通用和機(jī)密文件的日常對(duì)外披露，并存檔相關(guān)信息；思考影響工作效率的主要原因。 XVII. Collection and uploading of label information after the approval of Registration Certificate; Support compliance with label template and content. 負(fù)責(zé)注冊(cè)證書獲批后標(biāo)簽信息的采集與上傳；為標(biāo)簽?zāi)０搴蛢?nèi)容合規(guī)性方面的工作提供支持。 XVIII. Have in-depth understanding of domestic notarization and foreign affairs certification and relevant procedures. 對(duì)國(guó)內(nèi)公證、外事認(rèn)證及相關(guān)程序有深入了解。 XIX. Participate in Advertisement Examination. 參與廣告審查。 XX. Have basic knowledge on China BU strategy and market competition of key products. 對(duì)中國(guó)BU就重點(diǎn)產(chǎn)品的策略和重點(diǎn)產(chǎn)品的市場(chǎng)競(jìng)爭(zhēng)情況有基本的了解。 XXI. Communication & escalation: clearly describe the questions/needs, timely ask WWBU RA for documents & support; communicate with China cross function members on registration status; clearly communicate with reviewers on dossier contents and other external stakeholders (test lab, TC, etc.), influence in certain areas; frequently communicate with supervisor to report progress and escalate risks/issues. 溝通與上報(bào)：清晰描述問題/需求，及時(shí)向全球業(yè)務(wù)部門法規(guī)事務(wù)部索取文件和支持；與中國(guó)跨職能團(tuán)隊(duì)成員就注冊(cè)狀態(tài)進(jìn)行溝通；與審評(píng)員就注冊(cè)申報(bào)資料的內(nèi)容進(jìn)行清晰溝通，與其他外部利益攸關(guān)方（測(cè)試實(shí)驗(yàn)室、TC等）進(jìn)行溝通，在某些領(lǐng)域產(chǎn)生影響；經(jīng)常與主管溝通，以報(bào)告工作進(jìn)度并上報(bào)風(fēng)險(xiǎn)/問題。 XXII. Well practice self management skills, project management, time management, presentation, etc.; good sharing & teaming spirit; actively absorb knowledge from others & trainings; able to take critical role & additional accountabilities for team when needed (e.g. take additional complex projects when there's absence). 有效踐行自我管理技能、項(xiàng)目管理、時(shí)間管理、演講宣講等技能；具有良好的分享和團(tuán)隊(duì)精神；積極吸收來自他人傳授和從培訓(xùn)中獲得的知識(shí)；能夠在需要時(shí)為團(tuán)隊(duì)承擔(dān)關(guān)鍵角色和額外責(zé)任（例如：在相關(guān)人員缺席時(shí)承擔(dān)額外的復(fù)雜項(xiàng)目）。 Other responsibilities defined in written procedures. 流程中規(guī)定的其它職責(zé)。