Regulatory Affairs Manager法规注册经理

You should ensure products and quality management system complying with relevant international / national standards and regulations through the entire product life cycle.
1. You will be responsible for medical device registration / homologation in NMPA and other national competence authority. Renew and maintain all licenses and certificates according to business development requirements.
2. You will establish, maintain and optimize product registration / homologation and other compulsory certification process, ensure all documentation for product licensing are properly archived and maintained.
3. You will establish, maintain and improve quality management system. Ensure the quality management system is compliance with ISO 13485, China GMP and other regulatory requirements.
4. You will be responsible for Sub-contractor quality and process management. Regular audit to sub-contractor, include incoming, process and outgoing quality control.
5. You will be responsible for Post market surveillance management. Handling of adverse events, post market surveillance plan and report. Medical device reporting to authority.
6. You will communicate with local authority / NMPA and SHS China RA team for regulatory affairs, and improve the efficiency of product registration.
7. You will coordinate with relevant colleagues for authority quality system audit, factory inspection.

Your qualifications and experience:
1. You have Bachelor’s degree or above, major in Biomedical Engineering, Electrical Engineering, Physics, Mechatronics, Computer Science, etc.
2. You over 5 years’ regulatory affairs and quality management system working experiences.
3. Hands-on MAH experience is plus.