上海招聘

I. GENERAL SUMMARY & OVERALL CHALLENGES
In this role, you will prepare and arrange the registration test, prepare the submission dossier, submit and follow up the whole registration process. You will also be a key leader to summarize the gap analysis with BU supporting for new standards and regulations which are applicable on LMS product. The major responsibility of the position is working on product registration on time according to the priority of products defined by the executive team of the company and ensure product compliance with relative standards and requirements.
II. KEY RESPONSIBILITIES
Responsibility Measure of performance
Key role in RA strategy plan on product launch Get type test report as planned.
Get NMPA certificate as planned.
Responsible for registration dossier preparation and submission based on product launch planning and NMPA requirement.
Responsible for registration test protocol preparation and work closely with testing lab to perform the registration test based on registration planning and authority requirements.
Communicate closely with BU on the needs and problems of registration document and type test.
Follow up closely with CMDE and testing lab, and report the progress of product registration.
Support other functions on RA issues
III. REQUIREMENTS FOR THIS POSITION
At least 3 years’ RA experience in medical device.
Experience in active medical device registration is preferred.
Bachelor’s degree in biomedical engineering, clinical medicine, life science or related field.
Workable English skills

徕卡显微系统（上海）有限公司成立于1995年，是徕卡仪器（德国）有限公司在中国的全资子公司。位于浦东新区金桥出口加工区，其投资总额为1057万美元，注册资本为680万美元，总面积为10,000平米,员工近500人。2005年徕卡正式加入美国丹纳赫（Danaher）集团，成为丹纳赫生命科学及诊断事业部的一个重要分支。
公司目前主要有两大部门：光学显微系统（Leica Microsystems）和组织病理系统(Leica Biosystems)。
光学显微系统(LMS)包括生物显微镜和医学显微镜，规格从低端到高端，主要应用于教学、医学、科技应用及其它光学系统。作为全球显微制造行业中的佼佼者，公司拥有一流的生产设备和团队，同时其研发力量亦日趋增强。
组织病理系统(LBS)的产品涵盖切片机，脱水机，包埋机，染色机及其他实验室设备，覆盖组织学的每个步骤，并为整个实验室提供高效的工作流程方案。以提供最优质、最全面的病理产品为使命，公司在上海不仅建立了完善的装配生产线，同时也组建了强大的研发团队，从而打造适合中国和世界的一流的病理产品。