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

🧪 報名連結： https://ebc-july-ra.eventbrite.de

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活動資訊：

臺灣時間：2021 年 7 月 17 日 (六)

23:00-24:00 Career Talk

24:00-01:00 Speed Networking [ Zoom Breakout Room ]

德國時間：2021 年 7 月 17 日 (六)

17:00-18:00 Career Talk

18:00-19:00 Speed Networking [ Zoom Breakout Room ]

美東時間：2021 年 7 月 17 日 (六)

11:00-12:00 Career Talk

12:00-13:00 Speed Networking [ Zoom Breakout Room ]

美西時間：2021 年 7 月 17 日 (六)

8:00-9:00 Career Talk

9:00-10:00 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 University and a bachelor’s degree in Biology from Tunghai University. With more than 10 years of experience in regulatory affairs with different types of FDA regulated industry including biotech, pharma, and medical devices, he is currently based in San Diego with prior experience at Medtronic, Zest Dental Solutions, 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 certificate in Regulatory Affairs from the University of Southern California. He currently works as a Regulatory Affairs Specialist at an in vitro diagnosis (IVD) device company based in San Diego. His work primarily focuses on global registration in the EU and the rest of the world. Prior to his current position, he was a Quality Assurance/Regulatory Affairs Associate at Nihon Kohden America, a company 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 Zoom 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-bioindustry-club/

🧪 LinkedIn社團: https://www.linkedin.com/groups/9014660/