Job Description:

Accomplish appointed medical device product registration work on time, and report to company high level in time; accomplish other work appointed by Medical Device Registration department. 

Key responsibilities/essential functions include:

1. Establish and implement registration strategy to achieve normal approval;

2. Prepare product registration dossier, submit it and follow up with CFDA related department; 

3. Responsible for regular communication with Manufacturer and CFDA related department, and report to manager in time;

4. CFDA related Regulation & Policy collection and summary, to ensure the company regulation database refreshed real-time.

5. Assist regulatory manager to build the China local SOPs on regulatory operations and focus on implementation. 

6. Share regulatory affairs best practice with the team and provide necessary trainings to internal employees. 

7. Other task appointed by company high level. 

Quality Specific Goals:

1. Develop and maintain good communications with CFDA and testing centre etc.

2. Provide regulatory affairs advices and guidance before product launch;

3. Review Labeling/advertising to compliance with SFDA requirement.

 Required Qualifications:

1. Bachelor degree or above;

2. Fully understand the current regulatory practices and regulation in China, the authority structure and relationship among different regulatory bodies, knowing and building the relationship with key stakeholders.

3. 3 years+ medical device related CFDA experience is preferred.

 Preferred Qualifications:

1. Strong inter-personal skills and good communication skills.

2. Able to work with a keen sense of urgency and priority tasks.

3. Good command of writing and speaking in English or Japanese.