QA/RA Lead

Responsibilities

• 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...