職位描述
ROLE AND RESPONSIBILITIES
The Safety and Regulatory Engineer(SRE) role combines skills of Safety engineer and Regulatory affairs (pre and post market), and will engage in product development teams to ensure safety and compliance.
1、Engaging with program management team to provide SRE deliverables such as Compliance Plan and regulatory requirements, Technical Files.
與項(xiàng)目組合作撰寫各法規(guī)相關(guān)文檔。
2、 Work closely with regulatory, engineering, marketing, and other cross team to get all target countries regulatory compliance, including CFDA, 510K, CE etc.
與法規(guī)，工程師，市場團(tuán)隊(duì)一起保證產(chǎn)品符合銷售國家的法規(guī)，主要地區(qū)包括中國，美國和歐洲。
3、 Work closely with engineering team to pass typing test and TUV testing.
與工程師團(tuán)隊(duì)一起保證產(chǎn)品通過型式試驗(yàn)和TUV測試。
4、 Screening new regulatory requirement, interpret(Impact assessment), implement & compliance check, to ensure the products compliance and on time implement all new regulatory requirements.
篩選并解讀法規(guī)要求，保證產(chǎn)品設(shè)計(jì)符合法規(guī)要求。
5、 Support regulatory inspections as required
支持法規(guī)檢查。
6、 Other tasks assigned by the leader
其他未盡事宜。
QUALIFICATIONS AND EDUCATION REQUIREMENTS
1、Bachelor degree or above in science and technology majors.
學(xué)士學(xué)位及以上，科學(xué)技術(shù)相關(guān)專業(yè)。
2、At least 5 years Safety and Regulatory experience, medical device industry experience is preferred.
5年以上安全法規(guī)工程師經(jīng)驗(yàn)，醫(yī)療行業(yè)優(yōu)先。
3、Ability to communicate in English and Mandarin, written and spoken, Excellent interpersonal and team work skills.
具有良好的中英文寫作和口頭表達(dá)能力，有良好的團(tuán)隊(duì)協(xié)作和溝通能力。
4、Quick study ability and clear thinking.
快速學(xué)習(xí)能力以及思維清晰。
企業(yè)介紹
新瑞陽光粒子醫(yī)療裝備（無錫）有限公司是總部位于美國加州硅谷的NewRT Medical Systems, Inc.在中國的全資子公司。公司由一批來自全球頂尖放療設(shè)備廠商Varian, IBA, 美國著名大學(xué)和國家實(shí)驗(yàn)室的高級專家和高級技術(shù)管理人員創(chuàng)建，并獲得美元基金的巨額投資和無錫當(dāng)?shù)卣拇罅χС郑瑢Ｗ⒂谛乱淮跋褚龑?dǎo)放療裝置的開發(fā)、生產(chǎn)和銷售，立志打造世界水平的國產(chǎn)化先進(jìn)放療裝置。
公司誠邀有志于挑戰(zhàn)癌癥，造?；颊叩木⒓用?，共同打造中國創(chuàng)造的頂尖放療裝置，為癌癥患者帶來新的陽光！
