For our company in Shanghai, we are looking for a Regulatory Affairs Officer.Goals/Mission: Ensure medical products and process complying with relevant international and national standards and regulations. He or she reports to Regulatory Affairs manager.

Working Partners/Contacts:

- Internal: In charge of group of regulatory affairs, supporting R&D and company on compliance of relevant standards and regulations for new products.
- External: legal authorities, testing institutes, and contacts on regulatory issues in company.

What are my responsibilities?
- Ensure product and process compliance with relevant and international laws and regulations.
- Establish and maintain product market clearance and other compulsory certification process -

Responsible for market clearance and other compulsory certificate for new product
- Communicate with Government office and company internal relevant organization to set up a network to Improve market clearance process
- Cooperate and Coordinate closely with new project team to ensure market clearance and other compulsory certificate process smoothly and efficiently
- Well communicate with business unite about the progress and status
- Responsible for coordination of factory inspection from third party

What do I need to qualify for this job?

- Bachelor or above, with major with bio-medical engineering or medical device related.

- CET 6
- Language (excellent verbal and oral English)

   We are looking forward to receiving your online application. Please ensure you complete all areas of the application form to the best of you ability as we will use the data to review your suitability for the role.

NO. 40004392