Job Description
1.      Responsible for record-keeping of type Ⅰ powered medical instruments , and registration of the type Ⅱ;
2.      Maintain the implementation of ISO13485 quality system;
3.      Product registration and declaration( Including SFDA registration and CE certification);
4.      Update and maintenance of company certificates;
5.      Prepare product registration files with the development information provided by Research &Development department;
6.      Writing and edit files for product registration and declaration;
7.      Coordinate product development of Research& Development Department, follow up product declaration.
 
Requirements
1.      Understand registration procedure of related products;
2.      Understand the operation of clinical trials in hospitals;
3.      Understand CE/FDA approval and regulatory system;
4.      Familiar with registration of type Ⅱ products;
5.      Strong logic and analysis ability, good writing expression;
6.      Passionate and self-motivated, high professional virtue and strong ability in organizational coordination, design and execution of plans; good communication ability and interpersonal skills;
7.      Good command of English and Chinese, excellent in Chinese article writing, master of office software.