Title：Quality & Regulation Specialist

Department：Quality & Regulation Department

Report to：Director of Quality Regulation Department

1、Responsibilities

• Responsible for the product registration plan, keep track and update of it, including CFDA, FDA and CE;

• Responsible for the third party testing of medical devices, including submitting applications, writing and sorting out relevant documents;

• Follow up the relevant laws and regulations, provide assistance and guidance for other departments on the regulations of medical device. Be responsible for law and regulations training to employees;

• Responsible for the preparation or modification of relevant quality system documents;

• Responsible for the arrangement and track of internal and external review, as well as some  admin work of the company.

2、Basic Requirement

• Bachelor degree or above, more than two years working experience in medical device registration or regulation, and at least one successful experience in medical device product registration;

• Familiar with ISO9001 or ISO13485 quality management system, and know the laws and regulations of medical device industry;

• Good abilities in English reading and writing, learning, communication and problem-solving;

• Give priority to internal auditor certificate of the GB/T19001 or YY/T0287 medical device quality management system.