Quality And Regulatory Affairs Lead

Descripción y detalle de las actividades
- Develop and coordinate regulatory plans with full implementation of new and modified products.
- ** Surveillance** of the compliance of the Quality Management System.
- Suggests and implements measures to improve QMS performance.
- **Coordinate**regulatory research to support regulatory submissions and regulatory advice.
- Coordinate and prepare regulatory information, including 510ks, technical Files and others (as applicable) to compliant with international regulation.
- **Review** engineering changes (as applicable) to support regulatory compliance.
- File, update, and maintain regulatory submissions in accordance with current US and foreign regulations for facility registrations, certifications, and licenses.
- Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations.
- **Manage**Document Control area and assign task and responsibilities including but ...