Job Mission

- Get the country’s approvals of target countries

- Monitoring the development and implementation of domestic and international technical regulations and standards to effectively support our business interests

- Ensure all products in accord with different countries' regulations and standards 

- Maintenance of the license for manufacturer in the scope of medical device regulations 

- Interface for domestic or international registration stakeholders 

- Report directly to RA head

Responsibilities

- Get the country’s approvals of domestic and international market, which includes preparing the necessary documents with corresponding experts (e.g. product standard, A-doc etc.), arranging type test and clinical evaluation, submitting and recalling application, and so on.

- Maintenance of the license for manufacturer.

- Remain and understand current domestic and international medical device regulations and standards related to the products, be able to provide necessary consultation and training to colleagues about relevant regulations and standards.

- Ensure all products compliance with intended countries' regulations.

- Assess the regulatory impact of product & process change and change notification.

- Actively interfaces and engages with others across functions, departments, etc. and business hierarchy to deliver optimum business results.

- Other tasks are assigned by department manager.

Requirements

1. Bachelor’s degree or above in engineering, clinical or relevant areas with medical device experience;

2. More than 3 years’ experience in quality/project management; experience in leading team is a plus;

3. Familiar with the regulations of medical device, e.g. FDA QSR, EU MDR; NMPA GMP;

4. Have strong influence skills and good communication skills and coordination ability;

5. Experience with international colleagues and customers; capabilities to operate in foreign cultures;

6. Advanced English speaking and writing skills.