Experience

財團法人醫藥工業技術發展中心

• Regulatory Affairs Manager

  • Nov 2022 - Present

  1. 醫療器材技術文件輔導與撰寫 2. 美國/歐盟/台灣醫療器材產品註冊輔導 3. 醫療器材品質系統輔導 4. 臨床評估輔導與撰寫 5. 臨床試驗媒合與執行 6. 外部人才培訓課程講師 7. 政府計畫執行與政策建議報告研擬 1. 醫療器材技術文件輔導與撰寫 2. 美國/歐盟/台灣醫療器材產品註冊輔導 3. 醫療器材品質系統輔導 4. 臨床評估輔導與撰寫 5. 臨床試驗媒合與執行 6. 外部人才培訓課程講師 7. 政府計畫執行與政策建議報告研擬



A-SPINE Asia Co. LTD.

• Sr. Regulatory Specialist

  • Mar 2020 - Oct 2022

  ● MD technical documents review and write-up. ● Resposible for product's clinical evaluation, PMS, and risk management. ● Act a RPM, in charge of project management and cross-departmental communication. ● Familar with EU MDD/MDR, ISO 13485, ISO 14971. ● Product registration to Taiwan, EU and other overseas countries including Argentina, Mexico, Sri Lanka, Vietnam, Phillipine, Australia. ● Regulatory consultation & internal training. ● MD technical documents review and write-up. ● Resposible for product's clinical evaluation, PMS, and risk management. ● Act a RPM, in charge of project management and cross-departmental communication. ● Familar with EU MDD/MDR, ISO 13485, ISO 14971. ● Product registration to Taiwan, EU and other overseas countries including Argentina, Mexico, Sri Lanka, Vietnam, Phillipine, Australia. ● Regulatory consultation & internal training.



Protech Pharmaservices Corporation (PPC Group)

• Consultant

  • Jul 2019 - Sep 2019

  ● Responsible for providing strategy of the clinical trial application and product license registration in US and Taiwan.● CTD/eCTD and US FDA ESG setup training.

• Regulatory Specialist

  • Apr 2016 - Jul 2019

  ● Responsible for the clinical trial application and product license registration in US and Taiwan; the drug type includes chemical drug, biological drug (cell therapy, toxin), botanical drug, radiopharmaceuticals and combination product.● In charge of administrative review, CMC substantial review, CTD CMC writing, eCTD conversion, regulatory submission and regulatory lifecycle maintenance.● Provide the sponsor regulatory strategy and technical support for the regional-specific regulatory submission.● Act a RPM, responsible for project management and timeline planning.● Evaluate the business development plan and the project budget of RA department.● Maintain and upgrade the FDA ESG account and eCTD software.● CTD/eCTD internal training.● Establish SOPs. Show less



K-jump Health Co. Ltd.

• Regulatory Affairs and Quality Assurance

  • May 2014 - Apr 2016

  ● Responsible for product license registration and regulatory lifecycle maintenance. ● Responsible for quality system certification maintenance. ● Participate in the audit/inspection of the notified body, US FDA and TFDA. ● Update the region-specific regulations of medical device and IVD. ● In charge of document management and product verification. ● Responsible for product license registration and regulatory lifecycle maintenance. ● Responsible for quality system certification maintenance. ● Participate in the audit/inspection of the notified body, US FDA and TFDA. ● Update the region-specific regulations of medical device and IVD. ● In charge of document management and product verification.



中國化學製藥股份有限公司

• Engineer

  • Sep 2012 - Mar 2014

  China Chemical & Pharmaceutical Co., Ltd. ● Write validation protocol/reports, implement analytical method validation, and establish product specification and SOPs: ● Participate in US FDA preapproval inspection (PAI) and TFDA GMP inspection. ● Implement quality control testing and equipment calibration management. China Chemical & Pharmaceutical Co., Ltd. ● Write validation protocol/reports, implement analytical method validation, and establish product specification and SOPs: ● Participate in US FDA preapproval inspection (PAI) and TFDA GMP inspection. ● Implement quality control testing and equipment calibration management.