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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 Responsabilities Quality Assurance function through the following activities, but not limited toSupports general activities related to product,



including resolution of regulatory and quality issuesServes on Regional and Corporate level teams as assignedSuggests and debates alternative methods and procedures for solving problems and meeting changing related to importation, storage, distribution and commercializationEnsures that product is store according to correct storage conditionsDevelops initial and subsequent modifications to the product quality maintenance to delineate areas of responsibility, personnel requirements, and operational procedures within the programEvaluates contents of reports from quality assurance initiatives and confers with management personnel preparatory to revisions to product assurance programReviews procedures of departments and recommends solutions to procedure changes.Evaluates the non-conformances, providing a treatement and solutionConfers with representatives of material and service vendors to obtain informatio

Postúlate en Kit Empleo: kitempleo.com.ar/empleo/mq6f6

📌 Sr. QARA Specialist (Buenos Aires)
🏢 Teleflex
📍 Buenos Aires