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I.
NMPA paper document submission and approval letter
collection, including Class I filing and IFU filing.
NMPA紙質文件遞交和批件領取，包括一類備案和IFU備案等。
II.
Consultation appointment of NMPA before product
registration acceptance.
產品注冊受理前NMPA的咨詢預約。
III.
Fees for registration items, including registration
fee, test fee and translation fee.
注冊項目繳費，包括注冊費、檢測費、翻譯費等。
IV.
Management of electronic medical device registration
certificate, including download, archiving and release.
醫(yī)療器械電子注冊證的管理，包括下載、存檔和發(fā)布。
V.
Tracking and Statistics of Regulatory Submission and
Approval Information.
注冊遞交和批準信息的追蹤和統(tǒng)計。
VI.
Lifecycle Archiving of Product Registration
Application Dossiers.
產品注冊申報資料生命周期存檔。
VII.
Internal and external account authority management,
including NMPA government platform, testing institute, internal system, etc.
內部和外部賬戶權限管理，包括NMPA政務平臺、檢測所、內部系統(tǒng)等。
VIII.
Responsible for collecting CGUDID data and comprehensively
understanding relevant regulatory policies and processes.
收集CGUDID數據，并全面了解法規(guī)政策和流程。
IX.
Honghui system daily maintenance and data entry
check.
紅會系統(tǒng)日常維護和數據錄入檢查。
X.
Fully understand the
management of relevant Certificates of the Company, and the archive
path.
充分了解對公司相關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)：準確維護相關數據庫；執(zhí)行例行的批準后流程，例如貼中文標簽、文案審查等；及時評估LCM產品的變更通知，立即觸發(fā)必要的注冊活動；支持上市后舉措，例如審核、檢驗、召回……對潛在的監(jiān)管風險保持敏感。
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.
在需要時積極協助優(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（RA）相關的質量管理體系（QMS）流程的操作，包括職位說明（JD）、標準操作程序（SOP）/作業(yè)指導書（WI）。制定QMS的基礎知識并思考相關改進。 找出每個流程文件中的痛點，并與相關同事分享想法。
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：遵循公司標準操作程序（SOP）/作業(yè)指導書（WI）/常規(guī)流程指南；積極思考改進并提供思路。
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：對新法規(guī)、政策、標準和技術懷有好奇心和熱情；熟悉NMPA/CMDE/實驗室常見工作流程；通過自學或參與培訓正確解讀關鍵注冊要求，初步反思對項目/業(yè)務的影響和啟示；培訓全球業(yè)務部門法規(guī)事務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.
負責產品通用和機密文件的日常對外披露，并存檔相關信息；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.
負責注冊證書獲批后標簽信息的采集與上傳；為標簽模板和內容合規(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.
對國內公證、外事認證及相關程序有深入了解。
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.
對中國BU就重點產品的策略和重點產品的市場競爭情況有基本的了解。
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：清晰描述問題/需求，及時向全球業(yè)務部門法規(guī)事務部索取文件和支持；與中國跨職能團隊成員就注冊狀態(tài)進行溝通；與審評員就注冊申報資料的內容進行清晰溝通，與其他外部利益攸關方（測試實驗室、TC等）進行溝通，在某些領域產生影響；經常與主管溝通，以報告工作進度并上報風險/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、項目管理、時間管理、演講宣講等技能；具有良好的分享和團隊精神；積極吸收來自他人傳授和從培訓中獲得的知識；能夠在需要時為團隊承擔關鍵角色和額外責任（例如：在相關人員缺席時承擔額外的復雜項目）。
Other responsibilities
defined in written procedures.
流程中規(guī)定的其它職責。