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

其他信息
语言要求：英语
行业要求：全部行业
所属部门：Leica徕卡