Regulatory Affairs Specialist/法规事务

Regulatory Affairs Specialist (法规事务专员)


Working Place 工作地点：上海
This position will be based in Shanghai
  
Reporting Line 汇报对象：总经理
This position will report to General Manager

Function & Responsibilities 功能与职责
-       Manage the whole product registration issues for China (including regions of Hong Kong, Macau, Taiwan) ; 
        管理中国（包括香港、澳门、台湾地区）所有产品的注册事宜;
-       Prepare and compile documents according to NMPA rules/guidelines for product registrations (new registration, modified registration, renewal registration, etc) ;
        根据NMPA规则/指南准备和编制产品注册文件（新产品注册、变更注册、延续注册等）；
-       Close communication with NMPA regarding registration progress/evaluation questions/further requests;  
        与NMPA就注册进度/评审问题/进一步要求等保持紧密沟通；
-       Plan, coordinate and monitor product testing at local testing centers, acquire testing report timely; 
         计划、协调和跟踪当地检测中心的产品检测，及时获取检测报告；
-       Regular communication with headquarter regulatory department in terms of regulatory law/guideline change, local  requests, NMPA questions, testing problems, etc; 
         定期与总部注册法规部门就注册监管法律/指南变化、地方要求、NMPA问题、检测问题等进行沟通；
-       Conduct gap analysis between headquarter documents and local registration demands; 
        进行总部文件与国内注册需求之间的差距分析；
-       Closely monitor and analyze newly published registration rules/guidelines; 
         密切跟踪和分析新发布的注册规则/指南；
-       Prepare the regulatory related costs for annual budget; 
        准备注册相关的年度预算；
-       Maintain and update the database regularly for relevant registered products in the market; 
        定期维护和更新市场上相关注册产品的数据库；
-       Assist the GM to conduct internal quality management to comply the regulatory requirements; 
        协助总经理进行内部质量管理，以符合法规要求；
-       Coordinate local requests related to product/package label and user manuals issues with headquarter; 
        与总部就产品/包装标签和用户手册等事宜的国内要求进行协调；
-       Assist to process possible FSCA and product adverse events in the market; 
         协助处理市场上可能发生的 FSCA 和产品不良事件；
-       Assist to prepare the annual company self-inspection report to local regulatory authorities; 
         协助向当地监管部门准备年度公司自查报告；
-       Reponses to possible questions/requests/on-site inspections from local regulatory authorities; 
         及时对当地监管机构可能提出的问题/要求/现场检查进行响应；
-       Other tasks assigned by company 
         公司交办的其他工作


Qualifications 任职要求

Education 教育背景
-       Bachelor degree or above in medical/engineering related major (Medical Device Science/Engineering/Regulation/Quality Management, Biomedical Engineering, Pharmaceutical & Biological etc)

医学/工程类相关专业本科及以上学历（医疗器械科学/工程/法规/质量管理、生物医学工程、制药&生物等）



Experience 工作经验
-       Minimum 2 years working experience in regulatory affairs (active Class II/III medical device registration experience is a must) 
         至少2年注册法规事务工作经验（必须具备II/III类有源医疗器械注册经验）
-       Together with quality management experience is highly preferred 
         同时具备质量管理经验者优先；
-       Experience in clinical studies/CER compilation is a plus 
         有临床研究/CER 编制经验者优先


Capabilities 工作能力
-       Fluent in English: CET 4 or above 
         英语流利：CET 4 或以上
-       Able to work efficiently under high pressure and constrained time requirement 
        能够在压力和有限时间情况下高效工作
-       Self-motivated, excellent communication skills, and a good team player 
        具有自我激励、优秀的沟通能力和良好的团队精神
-       Well organized, proactive, initiative, analytics skills 
        具有良好的组织能力、前瞻性、主动性和分析能力
-       Strong project management and multi-task skills 
        较强的项目管理和多任务处理能力
-       Proficient in computer document skills (MS Office, Adobe or other pdf tools) 
        熟练的计算机文件处理技能（MS Office, Adobe或其他pdf工具）
-       Professional business ethics 
        良好的职业道德