长沙招聘

PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB:

1.Responsible for Biomerieux import and local products registration within regular time frame; contact with authorities (SFDA, SHFDA, NICPBP and so on) & hospitals in P.R. China for each key milestone progress, including QC test, Clinical Trial, registration submission, CMDE Q&A, panel meeting, follow up and consultation.

2.Coach junior RA and manage RA intern in day to day registration activities.

3.Support RA head and manager on registration special case as well as regulations watch-up.

MAIN ACCOUNTABILITIES:

1.Make strategic and tactic plan for each high priority registration project to deliver commitment;

2.On time deliver each registration target according to RA year plan, including new product, renew and product modifications;

3.In-depth regulation study and response related department’s questions to regulation;

4.Contribute and organize regulation investigation when new changes occur at authority, and share with RA team members and related impacted department;

5.Prepare registration submission files on time according to checklist, and actively communicate with corporate RA and other technical or project team for file buildup;

6.On time deliver QC report according to project timeline and maintain good relationship with QC test centers;

7.On time deliver clinical trial according to project timeline and maintain good relationship with CT;

8.Monitor the product changes in pipeline, and look after regulation trend and new CFDA related standards;

9.Organize registration record well and archive according to RA SOP and department procedures;

10.Coach RA junior members and interns to help them to get familiar with department SOP and registration process, and guide them in day to day operations.

KNOWLEDGE, LANGUAGE AND EXPERIENCE:

1.Master degree of biology, medical related major preferred

2.3-5 years’ RA experience in medical device industry, IVD preferred

3.Good interpersonal and communication skills

4.Quick response, result oriented, respect the timeline, good project management skills

5.Fluent English in both written and oral

6.Be able to work under pressure

      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。