前情提要 我本身是生科/医疗背景，今年会取得USC的RA/QA 硕士 有很基础的程式能力(主要是Excel的macro VBA跟入门级的python，但学的目的 都是用来减轻文书处理的压力，所以没有甚麽真正开发的经验) 目前是在美国从事医疗法规(RA: Regulatory Affairs) 跟品质保证 (QA: Quality Assurance) 的相关工作 现在刚进入一家医疗器材公司做QA/RA，算是刚入行的小菜鸟 由於近年来趋势的影响 现在有很多纯软体的医疗器材(Software as Medical Device)在发展 这一直以来都是我很有兴趣的医疗领域，尤其是也搭上了AI、ML的热潮 但我对於coding本身没有很有兴趣，不太可能转行去做软体工程师 所以是希望自己能够成为跨部门之间沟通的桥梁 之所以会有这个念头，是因为今年有幸参加了一个FDA的有关cybersecurity的 pre-submission meeting。在这个pre-submission中，我发现了一件事情我们的 RA director/consultant对於很多软体上的概念一知半解(虽然我也一知半解， 但从他们的对话中可以了解到这点，而且FDA最後要求再开一个pre-submission meeting且要求要有软体工程师在场，可以想像FDA的不满意XD) 这件事情让我察觉到，在面对多年资深的RA前辈们时，这可以是我未来的竞争优 势之一，毕竟某种程度上我也算是年轻世代(装年轻中) ，所以在这未来三年内 的职涯规划，我对於如何加强我的核心能力(RA/QA)算是很有方向，但是在软体 做为辅助能力的这块，我有点摸不着头绪，所以想来请教大家的看法，比如说你 认为适合的书籍(中英皆可)、线上课程(Udemy, etc)、Keyword等等都可以 感谢大家 最後附上Apple今年徵求RA时的JD，以供参考 --------------------------------------------------------------------------- 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 ------------------------------------------------------------------------------- -- 推 sandwichpope:小妹妹，你想要成为魔法少女吗？ 03/29 20:32 推 sandwichpope:要成为魔法少女的第一步就是要先熟练地使用魔法棒 03/29 20:32 推 sandwichpope:大哥哥的这根魔法棒可以让你做练习喔 03/29 20:32 推 sandwichpope:只要搓一搓，神奇魔法棒就会变长 03/29 20:32 推 sandwichpope:再用力搓搓，魔法棒就会产生魔法药水 03/29 20:32 推 sandwichpope:如果喝下魔法药水，你就能成为魔法少女了 03/29 20:32 --

※ 发信站: 批踢踢实业坊(ptt.cc), 来自: 74.10.120.206 (美国) ※ 文章网址: https://webptt.com/cn.aspx?n=bbs/Bioindustry/M.1572019407.A.99C.html ※ s1s1:转录至看板 CareerPlan 10/26 00:11 ※ s1s1:转录至看板 Soft_Job 10/26 00:14 不要这样～Q ___ Q 对啊，刚好结合两个我都很喜欢的领域(Health IT + Regulatory Affair) 不过真的要有资格可以丢也是三五年之後的事情惹 现在是小菜鸟，还在规划自己的职涯，哈哈 感谢B大跟W大～～ ※ 编辑: s1s1 (47.156.128.208 美国), 10/28/2019 00:59:16