- Review the complaints of external customers to improve quality policy and standard.
- Develop and maintain quality system, including Chinese Label and Manual Quality Management, Product complaint, Adverse Event, Recall handling, internal quality audit and management, distributor interface with corporate QA management etc.
- Set up registration plan based on the business needs, ensuring the business compliance with national regulations.
- Familiar with CFDA regulations, process, document review principle and technical requirements. Review registration dossier as internal examiner and guide the project team members to prepare registration documents.
- Prepare regulatory submissions and obtain regulatory permits, including import/export clearance in a timely manner
- Interact with and build rapport with regulatory agencies and notified bodies as required to perform effective and fast track approval of product registrations.
- Monitor the regulation development and regulatory trend in China, report the impact to the company.
- Organize and deliver regulatory education and dissemination of regulation information to the organization.
1. Bachelor degree or above in clinical laboratory, health/life science discipline or the equivalent knowledge and experience;
2. Solid knowledge and experience in RA of medical device (IVD preferred), ISO knowledge is preferred.
3. Minimum 5 years of professional experience in a regulated environment; solid relationship with authority and office.
4. Rich experience in product regulatory submissions and successful registration track record;
5. Strong interpersonal skills, sense of innovation, competency in coaching, team collaboration
6. Fluent in English and Microsoft office skills