职位详情

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