QA/RA Lead

• 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 withinternational 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 the activities that occur to be followinginternational regulation.

• Manage Document Control area and assign task and responsibilities including but not limited to resources and priorities.

• Manage and coordinate internal, external and supplier audits to follow national and international regulation.

• Participate in the performance of the environmental management system in accordance with current roles and responsibilities.

• Audit our systems based on standards requirements.

• Manages and supervises quality control and training reports for proper follow-up.

• Set and track quality assurance goals.

• Coordinate with internal / external quality assurance auditors to ensure legal compliance.

• Work with internal teams to increase customer satisfaction by improving the quality of the products.

• Support to all programs and initiatives in the areas of Hygiene, Safety, Environmental and Quality.

• Support for all programs and initiatives related to company's Internal Labor and securities regulations.