Sr. QARA Specialist

Position Summary

Supports Quality Assurance and Regulatory Affairs elements for Teleflex Logistics and Distribution Center within Argentina. Main activities include being the Technical Director to provide support on Technovigilance, local labeling processes, document control; quality systems training in accordance with internal procedures, external regulations, and international standards. Establishes metrics, analyzes trends and reports on employee training compliance data.

On the Regulatory side, the Specialist will develop strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction. Where applicable, this position will assist in mentoring and development of staff members as part of the role.

The Sr. RAQA Specialist supports global quality and regulatory projects impacting local operations.

Principal Responsibilities