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 withininternational 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.
Develop, implement, and maintain the Quality Management System that apply to t...