RA Specialist
Main Purpose of the Role
The RA Specialist will be responsible for the routine regulatory affairs and quality assurance of alloted products.

Key Responsibilities
- Take charge of all routine registration activities including testing, file preparation, submission, tracking registration process and achieve license target in fast and effective way.
- Assess regulatory impacts on various product changes.
- Monitor NMPA’s relevant registration regulations, policy and related standards. Ensure product comply to the requirements and standards.
- Maitain or develop good working relationship and cooperation with authorities (CMDE, Testing lab,etc.) to improve working efficiency.
- Ensure Zero finance impact caused by improper regulatory strategy in registration submission.
- Coordinate with cross functional team to ensure product registration approval on time, and also other regulatory related actives.
- Provide regulatory support on pre-market and post market cases on responsible product branding.
- Perform other duties as needed.

Skills and Competencies
Education / Professional Experience
- Bchelor’s Degree or above, Medical device related major
- 5+ years of relevant working experience in Medical device registration, especially passive medical device in MNC.
- Good verbal and written skills in English
Personal Competencies
- Fast learning capability
- Good cooperation skill to work with cross-function team
- Active attitude to responsible

其他信息

行业要求：全部行业