医学诊断产品临床及监管事务部经理/Clinical and Regulatory Affairs Manager (医疗器械) – medical products/device/healthcare technology (Shenzhen)
JPC TEXSON LTDChinaUpdate time: May 16,2020
Job Description

 

THE COMPANY :
  • A healthcare technology company
  • 一家致力探索、开发并建立开拓性医疗健康平台之企业,藉此运用生物医学科技及信息技术,让大众掌握可付诸于行动的健康信息及新科技。致力推动医疗健康发展,让最创新的医疗健康技术发明,造福我国及亚州地区普罗大众。
  • We explore, invent, and build empowering laboratory testing solutions and platforms to harness the power of biomedical sciences and informatics to deliver better healthcare solutions to individuals and communities with actionable information and results.
  • We aim to be a key driver that makes the most disruptive healthcare inventions widely accessible to the public in China and Asia.
  • Our mission is using biomedical sciences to detect cancers at early stages and uncover hidden values from health information
  • Initial focus is on the development and commercialization of technologies that can allow the early detection of disease
  • We are looking for 医学诊断产品临床及监管事务部经理 - with details as follows :
 
THE JOB :
  • 协助制定并落实医疗器械临床注册相关方案;
  • 与医院、大学及临床项目团队共同营运医学诊断产品临床研究项目;
  • 负责产品上市前的注册/备案、延续注册及变更注册资料的撰写和申报;
  • 跟踪产品检测及负责与食品药品监督管理局、技术审评中心、医疗器械质量监督检测中心及其他相关部门的沟通交流,定期总结并向上级及时汇报;
  • 监督产品生产,确保产品质量合规及供应链正常运作;
  • 跟踪注册检测、临床申请、临床试验等进度和结果的收集,负责与临床开发服务的合同研究组织公司及其他相关部门的沟通、协调;
  • 解决申报过程中遇到的问题及已上市产品在使用过程中存在的与注册相关的事宜;
  • 负责注册资料及原始记录归档及整理;
  • 负责产品注册法律法规的收集整理,及时组织讨论和培训;
  • 负责制定年度验证计划,负责验证方案、验证报告的审核及其实施指导;
  • 按时完成药监部门等各种统计、调查表的填报;
  • 按时完成领导交办的其他工作任务;
  • 负责研发及生产过程的质量管理和质量控制,健全质量考评体系,推行全面质量管理;负责规划和建立公司,生产工厂质量管理体系和管理制度,监督、执行并维护质量管理体系;
  • 组织编写公司质量管理体系文件,起草年度质量目标;
  • 负责供应商质量管理体系的评定、审核和再评价;
  • 负责出具不合格品处理意见的最终审批,产品质量追踪,不良事件上报制度;
  • 负责纠正预防措施计划和验收结果的批准;
  • 长期驻深圳办公室上班,并向香港总公司汇报;
  • 本科及以上学历,生物技术、医疗器械、医学产品工程等相关专业优先;
  • 熟悉医疗器械注册/备案相关的法规及国家和行业标准,有产品注册标准编写、注册文件准备、联系产品检测等事务的经验
  • 三年以上独立的二类或三类医疗器械/诊断试剂产品注册申报经验,并了解医学检验实验室运作;
  • 接受过ISO9001、13485 质量体系等知识培训,有医疗器械相关法规的培训者优先;
  • 具有良好的语言沟通能力、协调能力,能读写英语;
  • 有较强的文案撰写能力,文笔流畅,逻辑性强;
  • 工作认真踏实、细致严谨、责任心强,拥有部门管理能力
 
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