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.
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.
Please contact us if you think alike：
Tel.: 020-39388458 Fax：020-39388548 Zip code：511400 Add.: Room 603, Tian An Hi-Tech Innovation Plaza, No. 555, Panyu A venue, Panyu District, Guagnzhou, 511400