长沙招聘

职位描述：
PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB
Manage the team in charge of product registrations and provide support to the other functions for regulatory matters
1.Contribute to define and to implement the regulatory procedures mainly those pertaining to the obtaining and maintaining (renewal, modification) of regulatory approvals
2.Implement these procedures including the ones, which are corresponding to the highest degree of regulatory complexity. Prepare organized and scientifically valid regulatory files (technical documentation) and submission in a timely manner
3.Obtain regulatory approvals and renewals as required interacting with CFDA and other associated Authorities when required
4.Provides guidance to and represent RA on necessary project, creates, monitors and controls regulatory project schedules and regulatory strategy documents
5.Contribute to the ongoing regulatory watch (regulations, guidance and norms) with a specific focus on products covered by the job : monitor change in the regulatory environment, evaluate and communicate impacts to the interested parties (RA Corporate,etc)

MAIN MISSIONS
1.Ensure proper coordination of the activities of his/her group with internal functions and Corporate functions
2.Plan regulatory activities and ensure adherence with plan
Provide input to the supervisor for building the annual RA registration plan
Provide input on RA resources for building program and project budget
Ensure appropriate resource allocations and adherence to budget for his/her team
3.Contribute to the definition, update and implementation of the regulatory policies, procedures and training; ensure adherence to the procedures
4.Identify and specify applicable regulatory requirements. Communicate to the concerned structure appropriate solutions to meet these requirements (RA strategy document and updates)
5.Prepares various submission for product approval:
Must be autonomous on this management of registration files including response to regulatory agencies request for additional information
Provide technical support and guidance as need to his/her team for preparation of regulatory submissions
6.Reviews and approved labelling, promotional and advertising material to ensure compliance with applicable regulation
Manage communication with CFDA and other associated Authorities on defined matters as assigned by the supervisor.
Ensure collaboration and coordination with the other functions of the coordination of Regulatory activities
Report on activities as appropriate

Requirements:
1.Solid knowledge and experience in RA of medical device (IVD preferred) with at least 5 years relevant working experience
2.Strong command of English in both written and oral
3.Maintain good liaison with related CFDA authorities and well execute daily RA work 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。