Role Description

Develop and execute plan/strategy to get products registered for sales in Greater China.  Ensure product distribution and sales in Greater China are in compliance with Chinese & Taiwanese laws and regulations from RA and QA perspective, as well as company’s rules and requirements.

1. To develop product registration plans and budget of the RA&QA Department.
2. To be responsible for the planning and execution of annual objectives; monitor and improve progress.
3. To manage the RA&QA team to meet business needs and support consistent business growth in regulatory affairs and quality assurance areas.
4. To build a strong and professional team in technical knowledge and communication skills.
5. To develop high levels of credibility and forge solid and positive professional relationships with government authorities, manufacturers, other departments, in particular International QARA, and senior management of the company.
6. Manage the importation and local testing of product samples according relevant international, national and specific product standards
7. Prepare dossiers for submission to SFDA and manage their review through to approval
8. Actively participate in industry networks and conferences to maintain knowledge of current regulations and have influence over/ input into the development of new/ amendment of existing regulations.
9. Compliant to Code of conduct and other corporate policies. Adherent to applicable local laws and industry code of ethics including but not limited to FCPA, AdvaMed Code of Ethics. Do the right things and do things right.

Person Description

1. B.S. degree or the equivalent with clinical medicine, Medical Device, biomedicine engineer, material.
2. Tertiary qualifications in relevant discipline: Science , Medicine, Engineering or other
3. Approximately 10+ years work experience in medical device regulatory affairs and 3+ years team management experience in China
4. Expert knowledge of the Medical Device regulations (relevant statutes and practices)
5. Familiar with quality management system.
6. People management experience
7. Excellent project management skills
8. Excellent verbal and written communication in Mandarin and English languages