Regulatory Affair Specialist 法规注册专员
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：2017-03-28
- 工作地点：上海
- 招聘人数：1人
- 学历要求：本科
- 职位月薪：5-50万/年
- 职位类别：医疗器械注册
职位描述
职位描述：
1.岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB
Responsible for biomerieux 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 when necessary, follow up and consultation.
Support RA manager on registration special cases as well as regulations watch-up.
Responsible for maintaining and improving RA database and records, and office daily work as well.
2.主要职责 / 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 following and 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 related departments 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.
8、Familiar with company process and handle the office related work independently.
3.知识、语言和经验要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE
1）Bechelor 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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1.岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB
Responsible for biomerieux 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 when necessary, follow up and consultation.
Support RA manager on registration special cases as well as regulations watch-up.
Responsible for maintaining and improving RA database and records, and office daily work as well.
2.主要职责 / 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 following and 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 related departments 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.
8、Familiar with company process and handle the office related work independently.
3.知识、语言和经验要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE
1）Bechelor 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