长沙招聘

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

      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。