Eureka C.

-Ob/Gyn medical devices (Class II-IV) new products launch preparation: Nonclinical tests (Biocompatibilities..etc.), sample import arrangement -CER, STED, IFU, label review -PMDA/Notified body query correspondence -Maintenance of approvals and certifications (Change control and periodical renewal) -QMS compliance inspection applications -Insurance listing applications (Creation of insurance listing application forms) -Manufacturing and distribution/certification approval, notifications (including planning, collecting data) -Post Marketing Surveillance (Anseki) -製造販売承認／認証申請、届出（計画立案、資料收集、PMDA／NB 照会対応、特許申請、国内試験） -承認／認証の維持管理業務（変更管理、定期更新） -製品適合性調査申請 -製品市販後調査、不具合事象報告(安責) -保険収載業務（保険適用希望書作成等）

-Handling NMPA(China), TFDA(Taiwan), Class1-3 medical devices registration and approval -Filing pre-market submissions and preparing the application documents package, IFU amendment, biosafety/endotoxin tests -Assisting with FDA inspection, MDR Technical Documentation Assessment -Drafting Periodic Risk Assessment Report 中国国家薬品監督管理局（NMPA）、台湾食品薬物管理署（TFDA）におけるクラスI～III医療機器の薬事申請および承認対応 市販前申請（Pre-market submission）の実施、申請書類パッケージの作成、添付文書（IFU）の改訂、ならびに生物学的安全性試験・エンドトキシン試験の準備および対応 FDA査察対応およびMDRテクニカルドキュメンテーション評価（Technical Documentation Assessment）の支援 定期的リスク評価報告書（Periodic Risk Assessment Report）の作成

Data Entry, Medical translation, Argus Safety, Clinical Trials, MedDRA, Medidata RAVE, Microsoft office, Microsoft Excel, Oncology

•Ensures distribution of all required individual expedited and periodic reports for both clinical(phaseII~IV) and post-marketing projects to the Safety Submissions team if contracted to submit the reports. •Manage reporting/submission/distribution of safety reports/updates/information (e.g. SAE, SUSAR report, DSUR) to Local Health Authorities (LHA) and/or clinical operations in cooperation with other Country Organization Departments. •Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate. • Assist with departmental or project deliverables, and with preparation and processing of Individual Case safety Reports (ICSRs) • Monitor and route incoming information to the appropriate project • Records all ICSR documentation and tracks in accordance with sponsor/customer specifications; distributes incoming mail and faxes • Redacts patient identifying information/ images in accordance with data protection guidelines and ICH GCPs and GVP • Maintains understanding of global drug/biologic/device regulations, GCPs, ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study/program plans and the drug development process Data Entry, Medical translation, Argus Safety, Clinical Trials, MedDRA, Medidata RAVE, Microsoft office, Microsoft Excel, Oncology

•Ensures distribution of all required individual expedited and periodic reports for both clinical(phaseII~IV) and post-marketing projects to the Safety Submissions team if contracted to submit the reports. •Manage reporting/submission/distribution of safety reports/updates/information (e.g. SAE, SUSAR report, DSUR) to Local Health Authorities (LHA) and/or clinical operations in cooperation with other Country Organization Departments. •Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate. • Assist with departmental or project deliverables, and with preparation and processing of Individual Case safety Reports (ICSRs) • Monitor and route incoming information to the appropriate project • Records all ICSR documentation and tracks in accordance with sponsor/customer specifications; distributes incoming mail and faxes • Redacts patient identifying information/ images in accordance with data protection guidelines and ICH GCPs and GVP • Maintains understanding of global drug/biologic/device regulations, GCPs, ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study/program plans and the drug development process Local ICSR submission (China, Taiwan) • Perform submissions (by email or through portal) to local RA according to local RA requirements • Perform translation for source documents (English to Chinese XML and CIOMS) • Standardize and update local reporting guidelines according to local RA requirements • Manage submission timeline, queries, follow-up, testing processes regarding local RA submissions from global team/ sponsors

CECC COVID19 border restriction and entry permission administration work

Health promotion, nutrition balance, policies making, health in all policies Hosted 2nd Annual Community Nutrition Promotion Center Party under COVID-19: 400+ participants, 10+ press release at paper media

-Operated Contact Taiwan platform, an official recruiting platform under the Ministry of Economy. -Researched how the Dutch Universities(Amsterdam University, Eindhoven University, Rotterdam University,TU Delft University) helped their graduates in the international talent market during the outbreak of COVID19. FB: https://www.facebook.com/contacttaiwan/ HP: https://www.contacttaiwan.tw/main/index.aspx LN: https://www.linkedin.com/in/contacttaiwan/