Regulatory Affairs Specialist
梅里埃诊断产品(上海)有限公司
- 公司规模:150-500人
- 公司性质:外资(欧美)
- 公司行业:医疗设备/器械
职位信息
- 发布日期:2017-08-04
- 工作地点:上海
- 招聘人数:1人
- 工作经验:2年经验
- 语言要求:英语 熟练
- 职位月薪:0.8-1万/月
- 职位类别:医疗器械注册
职位描述
职位描述:
MAIN ACCOUNTABILITIES
1.Establish registration plan and on time deliver each registration target according to RA annual plan, including new product, renew and product modifications;
2.Study regulation in-depth and response related department’s questions to regulation;
3.Contribute and organize regulation investigation when new changes occur at authority, and share with RA team members and related impacted department;
4.Prepare registration submission files on time according to checklist, and actively communicate with corporate RA and other technical or project team for file buildup;
5.On time deliver QC report according to project timeline and maintain good relationship with QC test centers;
6.On time deliver clinical trial according to project timeline and maintain good relationship with CT;
7.Well organize registration record and archive according to RA SOP and department procedures.
KNOWLEDGE, LANGUAGE AND EXPERIENCE
1.Master degree of biology or medical related major preferred
2.1-3 years RA experiences in MD/IVD
3.Good command of English in both written and oral
4.Good interpersonal and communication skills
5.Be able to work under pressure
6.Responsiveness, respect of timeline and project management skill
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MAIN ACCOUNTABILITIES
1.Establish registration plan and on time deliver each registration target according to RA annual plan, including new product, renew and product modifications;
2.Study regulation in-depth and response related department’s questions to regulation;
3.Contribute and organize regulation investigation when new changes occur at authority, and share with RA team members and related impacted department;
4.Prepare registration submission files on time according to checklist, and actively communicate with corporate RA and other technical or project team for file buildup;
5.On time deliver QC report according to project timeline and maintain good relationship with QC test centers;
6.On time deliver clinical trial according to project timeline and maintain good relationship with CT;
7.Well organize registration record and archive according to RA SOP and department procedures.
KNOWLEDGE, LANGUAGE AND EXPERIENCE
1.Master degree of biology or medical related major preferred
2.1-3 years RA experiences in MD/IVD
3.Good command of English in both written and oral
4.Good interpersonal and communication skills
5.Be able to work under pressure
6.Responsiveness, respect of timeline and project management skill
职能类别: 医疗器械注册
公司介绍
生物梅里埃公司创建于1963年,公司以来自身的科技创新和工业生产资源,始终致力于医疗和工业用途的体外诊断产品。生物梅里埃的诊断系统由试剂、仪器和软件组成,主要围绕感染性疾病、工业微生物、心血管病和肿瘤四个战略领域设计。生物梅里埃的使命是通过体外诊断,为全球公共卫生事业做出贡献。
目前,生物梅里埃在全世界拥有19个工业生产工厂;20个研发基地;业务遍及世界六大洲160个国家,在44个国家和地区设有分支办事机构;全球雇员近13000人。凭借55年的经营,生物梅里埃如今在全球体外诊断行业扮演着重要的角色,在全世界诊断企业排名中位列前十,是临床微生物学和工业微生物学领域的翘楚。
放眼未来,生物梅里埃将继续秉承传统、恪守承诺,全力为客户研发和提供***整体解决方案,力争成为推动全球公共卫生事业发展的领导者。
目前,生物梅里埃在全世界拥有19个工业生产工厂;20个研发基地;业务遍及世界六大洲160个国家,在44个国家和地区设有分支办事机构;全球雇员近13000人。凭借55年的经营,生物梅里埃如今在全球体外诊断行业扮演着重要的角色,在全世界诊断企业排名中位列前十,是临床微生物学和工业微生物学领域的翘楚。
放眼未来,生物梅里埃将继续秉承传统、恪守承诺,全力为客户研发和提供***整体解决方案,力争成为推动全球公共卫生事业发展的领导者。
联系方式
- Email:china@biomerieux.com
- 公司地址:上海市浦东新区浦三路4633号