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Information Resources Management Association
Advancing the Concepts & Practices of Information Resources Management in Modern Organizations

Stéphanie Monteiro

Stéphanie Monteiro is a senior quality and regulatory affairs professional with extensive experience across the pharmaceutical, medical device, and medical technology sectors. Her professional background encompasses quality management systems, regulatory compliance, risk management, and product lifecycle governance in highly regulated healthcare environments, including pharma, MedTech, and medical device innovation contexts. She has built her career at the intersection of quality, innovation, and operational excellence, contributing to the development, validation, and continuous improvement of products and processes in accordance with international regulatory frameworks and standards. Her expertise includes quality assurance, compliance strategy, process optimization, and cross-functional collaboration with R&D, clinical, regulatory, and executive leadership teams. Stéphanie is actively involved in academic and applied research initiatives related to medical technology, healthcare innovation, and organizational performance, and has contributed to several academic publications and edited volumes in these domains. Her professional and academic interests focus on how quality systems, human capital, and leadership practices enable sustainable innovation and performance in regulated industries.
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