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.
与项目组合作撰写各法规相关文档。
2、 Work closely with regulatory, engineering, marketing, and other cross team to get all target countries regulatory compliance, including CFDA, 510K, CE etc.
与法规，工程师，市场团队一起保证产品符合销售国家的法规，主要地区包括中国，美国和欧洲。
3、 Work closely with engineering team to pass typing test and TUV testing.
与工程师团队一起保证产品通过型式试验和TUV测试。
4、 Screening new regulatory requirement, interpret(Impact assessment), implement & compliance check, to ensure the products compliance and on time implement all new regulatory requirements.
筛选并解读法规要求，保证产品设计符合法规要求。
5、 Support regulatory inspections as required
支持法规检查。
6、 Other tasks assigned by the leader
其他未尽事宜。

QUALIFICATIONS AND EDUCATION REQUIREMENTS
1、Bachelor degree or above in science and technology majors.
学士学位及以上，科学技术相关专业。
2、At least 5 years Safety and Regulatory experience, medical device industry experience is preferred.
5年以上安全法规工程师经验，医疗行业优先。
3、Ability to communicate in English and Mandarin, written and spoken, Excellent interpersonal and team work skills.
具有良好的中英文写作和口头表达能力，有良好的团队协作和沟通能力。
4、Quick study ability and clear thinking.
快速学习能力以及思维清晰。

新瑞阳光粒子医疗装备（无锡）有限公司是总部位于美国加州硅谷的NewRT Medical Systems, Inc.在中国的全资子公司。公司由一批来自全球顶尖放疗设备厂商Varian, IBA, 美国著名大学和国家实验室的高级专家和高级技术管理人员创建，并获得美元基金的巨额投资和无锡当地政府的大力支持，专注于新一代影像引导放疗装置的开发、生产和销售，立志打造世界水平的国产化先进放疗装置。

公司诚邀有志于挑战癌症，造福患者的精英加盟，共同打造中国创造的顶尖放疗装置，为癌症患者带来新的阳光！