岗位介绍

职责描述：
This position is responsible for leading, directing and coordinating regulatory compliance mainly focus on ISO13485/FDA QSR820 and ISO9001 quality management system.
1. Implement and maintain the Quality Management System and defining standard operating procedures for ISO13485/ISO9001.
2. Be responsible for organizing external/ internal /Client audit and leading improvement of audit issue.
3. Report the supplier’s audit status to management team by regular meeting.
4. Be able to organize and host the management review meeting.
5. Participate in maintenance and continual improvement the quality management system of medical and consumer electronica products.
6. Familiar with EHS/CSR, leading the supplier QMS/CSR/EHS audit.

任职要求：
1. Min 5 years relevant experience in regulatory field for ISO9001 and ISO13485 of medical device quality management system.
2. Strong knowledge in regulations of ISO13485, FDA, QSR and CFDA.
3. Strong executive & leadership skills.
4. Familiar with medical products registration to international and domestics markets.
5. Possess excellent interpersonal and good communication skills.
6. Good team player and with effective in communication.
7. Good command of both spoken and written English and Mandarin.