［講座訊息］A career in regulatory affairs - 生技

【EBC職涯沙龍】

[A career in regulatory affairs]
什麼是Regulatory affairs (RA) specialist 法規專員？
在生醫製藥領域，法規專員負責申請藥品或醫療器材上市相關的法規要求，並確保該品項
在特定國家或跨國市場順利上市。
本場講座將分享法規專員須具備的專業技能與工作內容、美國相關求職經驗，並於講座後
安排networking時間和各國生醫人才認識與交流，歡迎大家共襄盛舉！

本次活動將由在美國擔任法規專員的 David Lin 及 Shane Chen 分享在美國的工作經驗
與求職技巧。

在這場講座裡你會學到：
RA 的工作範疇
RA 所需的技能和經驗
美國 RA 的求職經驗分享
RA 的職涯展望

誠摯邀請大家參加 EBC 社團職涯沙龍，並關注 EBC 官網追蹤未來更多的活動喔！
報名連結： https://ebc-july-ra.eventbrite.de
EBC 官網：https://eternalonetw.com/
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活動資訊：
臺灣時間：2021 年 7 月 17 日 (六)
23:00-00:30 Career Talk
00:30-01:30 Speed Networking [ Zoom Breakout Room]

講者：
David Lin, RAC
Regulatory Affairs Professional, USA

David received his Master’s degree in Regulatory Affairs from Northeastern Un
iversity and a bachelor’s degree in Biology from Tunghai University. With mor
e than 10 years of experience in regulatory affairs with different types of FD
A regulated industry including biotech, pharma, and medical devices, he is cur
rently based in San Diego with prior experience at Medtronic, Zest Dental Solu
tions, and Bachem Americas. He is fascinated with cutting-edge technology that
focuses on helping patients.

Shane Chen
Regulatory Affairs Specialist, USA

Shane received his Master’s degree in Medical Product Quality and a certifica
te in Regulatory Affairs from the University of Southern California. He is cur
rently a Regulatory Affairs Specialist at an in vitro diagnosis (IVD) device c
ompany based in San Diego. His work primarily focuses on global registration i
n the EU and the rest of the world. Prior to his current position, he was a Qu
ality Assurance/Regulatory Affairs Associate at Nihon Kohden America, a compan
y that produces devices for bedside vital sign monitoring.

溫馨小提醒：職涯沙龍的 Zoom 連結將在活動前一天以 E-mail 發送！會後還有 Zo
om Breakout Room 把握機會拓展人脈！


最後，歡迎追蹤 EBC (EternalOne BioIndustry Club) 臉書粉絲專頁、Instagram，
如果是生技業界同行請加入 LinkedIn 社團，以獲得未來最新的活動資訊喔！連結如下：
Facebook: https://www.facebook.com/EternalOneBioIndustryClub/
Instagram: https://www.instagram.com/eternalone.bioindustry.club
LinkedIn company page: https://www.linkedin.com/company/eternalone-bioind
ustry-club/
LinkedIn社團: https://www.linkedin.com/groups/9014660/


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