My client is a fast growing Medtech company looking to extend their presence in the China market. They are committed to developing solutions for precision diagnostics and therapeutics, to find the right diagnosis and treatment for the patients.
This role will be responsible for Medical Device Quality Management System(QMS) operations in accordance to China requirements and Product registration for NMPA(CFDA) of company's products.
Responsibilities:
- Establish QMS strategies in Shanghai and product registration for NMP
- Write/edit/review QA/RA related documents for product registration and distribution in China
- Research and understand related regulations and communicate across to HQ
Requirements:
- More than 7 years of QA/RA experiences in medical device or pharma industry
- Qualified with certificates of internal auditor(YY / T 0287 (ISO 13485) or GB / T19001 (ISO9001)) or obtaining same-level training or education
- Familiar with QA process for medical device
- Fluency in English
If you are a driven and growth minded individual who wants to grow alongside a reputable organization with exciting growth plans ahead, please apply with your CV.
