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陳俊伊(gene)

喜歡打羽球與跑步。以身為科學人為榮,主修免疫學。最喜歡的名言是"Opportunity will not come to the people,only people to look for opportunities"

Regulatory Affairs
Taipei Special Municipality,TW
[email protected]


工作經歷

福寶科技 FreeBionics corporation, 醫療器材法規工程師 Regulatory Affair, Mar 2020 ~ 現在

1. 維護醫療器材證照與追蹤法規更新(CE/FDA/TFDA)
2. 執行國內外醫療器材產品法規認證(CE/FDA/TFDA)
3. 負責品質系統建置與運作執行(MDSAP, ISO13485, GMP, QSR820,MDR)
4. 產品法規、標準之蒐集/彙整更新及維護
5. 品質系統稽核相關試務
6.協助 ISO文件制訂及管理
7.執行矯正預防措施規劃、追縱及結案
8.上市後監督(PMS),異常事件通報

1. Maintenance the medical device license (CE/FDA/TFDA).
2. Apply local medical device license (CE/FDA/TFDA).
3. Operating quality management system (MDSAP, ISO13485, GMP, QSR820,MDR).
4. Update foreign medical regulation.
5. Internal audit management.
6. Written ISO document.
7. Operating correction and prevention action and follow up the situation.
8. Post-Market Surveillance, report serious adverse event.

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國光生技 Adimmune corporation, 助理工程師 Assistant Engineer, Mar 2019 ~ Mar 2020

1. 執行變更管制,撰寫SOP
2. 執行無菌充填製程
3. 翻譯FDA、賽諾菲稽核查廠缺失
4. GMP相關文件與定期審閱
5. 作業場所清潔消毒
6. 製程產線作業(調劑、充填、包裝)
7. 設備操作、驗證與確效、預防保養執行

1. Writing Change Control document, helping English document translation. 

2. Control Aseptic vaccine filling procedure. 

3. Helping translate URS, ISO and FDA inspection document.

 4. Review GMP document. 

5. Manage sterilize procedure. 

6. Validation and verification management.

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學歷

慈濟大學醫學檢驗生物學研究所, 科學碩士(MS), 免疫學(Immunobiology), 2017 ~ 2018


慈濟大學, 理學士(BS), 生命科學(Life Sciences), 2013 ~ 2017

榮獲Istumate創創黑克松IOT類組優等獎
協助舉辦第一屆TRANS從醫到零-跨域生醫新創論壇
獲得鳳凰志工三年榮獲總隊長獎
擔任第13屆慈大羽球社社長

自傳

  畢業於慈濟大學生命科學系、醫學檢驗生物技術學系所,研究所方向為免疫系統的耐受性。大學期間曾參與新創競賽、黑客松,也擔任過社團社長。自學python, Javascrip, HTML, CSS,也擔任緊急救護專員,曾在消防局擔任救護志工3年,喜歡突破自我,不會為自己畫設界線。 


   畢業後在國光生技擔任助理工程師,國光生技為全台最大的人用疫苗廠,我在工廠執行疫苗量產作業,主要執行疫苗無菌充填製程。另外學會環境消毒、滅菌、設備卻校與驗證。


   之後轉職到福寶科技,福寶科技為全台第一家國產動力式下肢外骨骼機器人,主要提供服務給脊髓損傷的病患使用。我在公司擔任醫療器材法規工程師,主要執行內部稽核、維護產品登記證有效性、市場合規性與產品合規性、法規資訊收集、維護品質系統有效性(MDSAP)、通報流程、矯正預防措施開立與追蹤。


  I was graduated from Tzu Chi University, and my major in postgraduate degree is immunology. I was focused on the effect of intestine immune response by the fungus. During this time, I learned how to use flow, mass spectrometer and many science techniques.


   The first occupation was in Adimmune corporation, which is the biggest human use Vaccine in Taiwan. Thus, I was an assistant engineer at that time. Working in the largest vaccine in Taiwan, my main duty is to make sure the sterilize procedure for drug injection into the syringe. Moreover, I have learned Validation and verification management, review GMP document, writing change control document and helping English document translation. 


   Later I was moved to FreeBionics corporation, which is the first company in Taiwan to design exoskeleton devices for spinal cord injury patient. I work as a regulation affair in this company. In this company, my job is to maintain the medical device license, apply local medical device license, update foreign medical regulation, operating quality management system, operating correction and prevention action and follow up the situation ,post-Market Surveillance and report serious adverse event. 

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