職涯規劃 - 生技

前情提要
我本身是生科/醫療背景，今年會取得USC的RA/QA 碩士
有很基礎的程式能力(主要是Excel的macro VBA跟入門級的python，但學的目的
都是用來減輕文書處理的壓力，所以沒有甚麼真正開發的經驗)
目前是在美國從事醫療法規(RA: Regulatory Affairs) 跟品質保證
(QA: Quality Assurance) 的相關工作
現在剛進入一家醫療器材公司做QA/RA，算是剛入行的小菜鳥

由於近年來趨勢的影響
現在有很多純軟體的醫療器材(Software as Medical Device)在發展
這一直以來都是我很有興趣的醫療領域，尤其是也搭上了AI、ML的熱潮
但我對於coding本身沒有很有興趣，不太可能轉行去做軟體工程師
所以是希望自己能夠成為跨部門之間溝通的橋樑

之所以會有這個念頭，是因為今年有幸參加了一個FDA的有關cybersecurity的
pre-submission meeting。在這個pre-submission中，我發現了一件事情我們的
RA director/consultant對於很多軟體上的概念一知半解(雖然我也一知半解，
但從他們的對話中可以了解到這點，而且FDA最後要求再開一個pre-submission
meeting且要求要有軟體工程師在場，可以想像FDA的不滿意XD)

這件事情讓我察覺到，在面對多年資深的RA前輩們時，這可以是我未來的競爭優
勢之一，畢竟某種程度上我也算是年輕世代(裝年輕中) ，所以在這未來三年內
的職涯規劃，我對於如何加強我的核心能力(RA/QA)算是很有方向，但是在軟體
做為輔助能力的這塊，我有點摸不著頭緒，所以想來請教大家的看法，比如說你
認為適合的書籍(中英皆可)、線上課程(Udemy, etc)、Keyword等等都可以
感謝大家

最後附上Apple今年徵求RA時的JD，以供參考

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Summary
The ealth group is looking for a Regulatory Affairs Associate to
help drive strategy and submissions for health products. If you are
passionate about the health space and want to have an incredible
impact here at Apple, this could be the role for you. We are an
efficient team who works closely together to build relationships
across multiple functional teams. We care deeply about getting
amazing new products into our customers hands.

Key Qualifications
‧ 5+ years of medical device experience in a regulatory compliance role
‧ Shown Experience In Interactions With Regulatory Bodies.
‧ Preparing global product submissions required.
‧ Strong working knowledge of US, EU, and APAC and LATAM regulations
that affect Class I, II and III devices
‧ Strong knowledge of global regulations

Description
‧ You will represent the RA/QA team on a diverse array of
regulatory initiative teams and new product development, with the
goal of commercializing new technologies. You will demonstrate the
ability to develop a variety of solutions to regulatory challenges
and will exercise independent judgment in settling and communicating
appropriate regulatory action and requirements. This role will
involve assessment of regulatory impact for new and modified Class I,
II and III products, including identification of assumptions/risks/mitigations
to develop and execute clear regulatory plans.

Education & Experience
‧ B.S. ME/EE/BME/CS degree or equivalent in any engineering discipline

Additional Requirements
‧ Working as part of a focused project team.
‧ Proven competence in determination of appropriate global regulatory
requirements for new products or product changes.
‧ Partnering with and across engineering teams to set regulatory strategy
‧ Strong organizational and management skills
‧ Excellent communication skills, both verbal and written

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