• 3-4年经验
  • 本科
  • 招1人
  • 11-14 发布
  • 五险一金
  • 餐饮补贴
  • 补充公积金
  • 通讯补贴
  • 专业培训
  • 出国机会
  • 交通补贴
  • 年终奖金

职位描述

职位描述: Job descriptionTitle: Regulatory ManagerResponsibilities:?Manage regulatory affairs vis-à-vis CFDA and medical device testing institutes;?Transform development and technical documents into registration documents;?Create and maintain regulatory dossiers, and document all changes and modifications to the dossiers;?Make applications for testing and registration to CFDA and testing institutes, follow-up on the applications and answer queries in coordination with engineers and R&D staff in Israel;?Assist and coordinate with clinical operations staff for related activities;?Coordinate with CROs for related activities.Qualifications:?Education: bachelor degree in life-science related majors or electronic engineering;?Experience: 3 - 5 years in medical device regulation, experience in vital sign monitoring devices preferred; familiar with the whole regulation cycle of a new medical device product (class 2 or 3); familiar with device-related laws, regulations, and guidelines, and be able to follow changes in such laws, regulations and guidelines;?Language: proficient English; good written English skill; able to communicate and solve complicated technical issues with colleagues abroad by email correspondence and voice/video conference;?Proactive, initiative, and well-organized; problem-solver. 职能类别: 医疗器械注册

联系方式

南云二路62号

公司信息

Sterling is a US-based international HR management consulting firm with big operations and great success in China with business scope in executive search, psychological assessment, campus recruiting, market intelligence research, salary survey and other related HR services. As the first American HR management consulting firm to enter China in 1992, Sterling has since established office and alliance office in Shanghai, Beijing, Tianjin and Chengdu and has built solid partnership with our clients and enjoyed excellent reputation in China market优异人力资源顾问公司(Sterling 猎头)是一家国际猎头公司,于1982年成立于美国,在90年代业务扩展到亚洲,1992年在北京创立第一家分公司。优异人力资源顾问公司的服务项目主要有猎头服务、校园招聘、人力资源咨询服务、高管评估、人力资源外包、员工态度调查、组织设计分析等。公司在中国、新加坡、日本、印度、韩国、英国等地区设立分公司或office。优异人力资源顾问公司(Sterling 猎头)的服务客户主要为财富1000强、上市公司和优秀的本土企业;Sterling 猎头具有三十多年的人力资源服务经验,具备丰富的人力资源行业知识,引领世界人力资源行业发展;公司建立了丰富的人才资源库,并与本土文化进行充分的融合,为企业客户提供优质的服务。

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