Position Overview

Responsible for obtaining regulatory approvals in China. Execute the regulatory affairs activities for MicroVention Inc. including new product, license change and extension, and ensures compliance to NMPA including ISO 13485, NMPA local, state and/or federal requirements. Coordinate the NMPA post market inspections within the company.

此岗位主要负责在中国的注册工作,执行所有美科微先公司及旗下公司法规事务发面的相关工作包括新产品注册,变更注册,延续注册以及相关的合规事务包括但不限于ISO 13485, 当地,省市和中国药局的法规政策。

Job duties:
  • Develop and execute the regulatory Strategy and plan. 制定和执行注册策略和计划。
  • Process all payments timely and correctly. 保证付款按时和准确
  • Represent Regulatory on project teams and partners with the cross functions on the team to ensure alignment of regulatory strategy and plans with the team objectives. 代表项目团队的监管员和跨职能团队的合作伙伴,确保注册策略和计划与团队目标一致。
  • Ensure submission quality. 确保注册申报资料质量。
  • Identify regulatory requirements of MVI and China market. 确定公司市场部和中国市场的注册要求。
  • Write, review, and file regulatory submissions and dossiers to NMPA to ensure MicroVention devices are commercially available in China based on the approved regulatory strategy. 撰写、审查和归档向NMPA递交的注册申报资料,根据已批准的注册策略,以确保美科微先公司器械在中国上市。
  • Communicate with NMPA test lab for related type test topics to ensure to obtain the type test report. 与中国药局检测实验室沟通相关注册检测主题,以确保获得注册检测报告。
  • Communicate with CMDE on routine submission matters such as submission files, supplementary notice response, etc. 与器审中心(CMDE)沟通注册申报文件、补正资料通知回复等常规注册申报事宜。
  • Document, consolidate, and maintain verbal and written communication with the CMDE, NMPA, and test lab. 记录、整合和维持与CMDE、NMPA和检测实验室的口头和书面沟通。
  • Review change order documents and ascertain impact on current regulatory approvals. 审查变更指令文件和确定对当前注册审批的影响。
  • Develop and maintain regulatory files and records. 制定和维护注册文件和记录。
  • Support MicroVention China Joint Venture GMP inspection. 支持美科微先公司中国合资企业良好作业规范(GMP)检查。
  • Ensure product labeling meets China regulation. 确保说明书和标签的内容符合中国法规的要求
  • Good teamwork. 良好的团队合作
  • Perform other duties and responsibilities as assigned by management. 执行管理层分配的其他任务,并履行其他职务和职责。

    1. Minimum BA/BS Degree or higher in Science, Engineering or Medical Technology (or equivalent related experience).科学、工程或医疗技术(或同等相关经验)BA/BS学位或以上学历
    2. A minimum of one (1) year of professional Regulatory Affairs experience.至少1年专业法规事务经验
    3. Documented experience in preparing of China submission (implant and catheter experience preferred).具有中国注册申报资料编制文案经验(植入物和导管经验优先)
    4. Experience interfacing with relevant China Regulatory Affairs such as NMPA, CMDE, and labs.具有与相关中国法规事务机构(如NMPA、CMDE和实验室)对接经验
    Desired Qualifications
    1. A minimum of one (1) year of medical device industry experience preferred. 1年以上医疗器械行业经验优先
    2. Experience in Medical Device China Submission. 具有医疗器械中国注册申报经验
    3. Registration experience in neurovascular and cardiovascular medical device in China preferred. 有中国神经血管和心血管医疗设备注册经验的人优先
    4. Knowledge about pre-clinical and post-clinical study. 具备临床前和临床后研究相关知识
    5. Basic knowledge about Biocompatibility Test. 具备生物相容性试验相关基本知识
    6. Ability to comprehend technical documents and concepts. 能够理解技术文件和概念
    7. Good communication skills, patient and careful, good at cooperation. 良好的沟通能力,有耐心和细心,擅长合作
    8. Ability to work well in a cross-functional team environment. 能够在跨职能团队环境中高效工作
    9. A self-starter with the ability to work autonomously. 做事主动,自主工作能力
    10. Proven analytical abilities and organization skills. 具备成熟的分析能力和组织能力
    11. Proficient with MS Word, Excel, and Outlook. 精通MS Word、Excel和Outlook等办公软件