长沙招聘

职位描述：
岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB
This position is responsible for monitoring and coordinating the post-market related activities implementation including AE, Recall and etc. to ensure the regulatory compliance; to maintain and enhance a good relationship with related authorities including CFDA, SHFDA, AQSIQ etc. and to ensure the smooth communication both internally and externally.

主要职责 / MAIN ACCOUNTABILITIES
Adverse Event (AE) Handling
a) Identify the reportable AE;
b) Lead the cross-functional teams to work out proper report;
c) Ensure all adverse events, which include local and oversea AE reporting are handled in timely manner and comply with regulation and BMX requirements;
d) Perform Competent Authority communication.

2. Recall & Correction Management timely
a) Lead the cross-functional team to handle all the recalls in timely manner;
b) Support related function on communication preparation and ensure appropriate internal information sharing;
c) Ensure all Recalls are handled in timely manner and comply with regulation and BMX requirement;
d) Perform Competent Authority communication

3. Post-Market Surveillance monitoring
Follow regulation involvement and timely deliver related trainings to the team;
Ensure traceability of all PMS related activities;
Support RA on renew registration documentation preparation.
Support related process owner for continuously process improvement


知识、语言和经验要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE
1. Education background: biological Engineering, Pharmaceutical related are preferred.
2. at least 1 year RA/QA working experience and PMS activity experience preferred
3. Good command of English in both written and oral
4. Good communication and interpersonal skills
5. Team work and take initiatives
6. Work under pressure 举报 分享

      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。