Iris Leinwand

Iris Leinwand, B.Pharm., MBA, is a highly experienced consultant and lecturer specializing in quality management systems and regulatory compliance for the medical device and in-vitro diagnostics industries. She brings nearly three decades of combined pharmaceutical, innovation, and medical device expertise. Iris began her career at Sanofi-Aventis, where she held senior roles in Regulatory Affairs, international marketing, and product management in Israel and France, leading product registrations, corporate strategy development, and cross-regional commercial initiatives. She later joined Systematic Inventive Thinking (SIT) as an Innovation Associate and Senior Facilitator, delivering high-impact innovation and problem-solving programs for global organizations across the healthcare, technology, and industrial sectors. Since joining R&Q Consulting Ltd. full-time in 2014, Iris has served as a senior consultant to medical device companies, supporting the establishment, implementation, and auditing of quality management systems compliant with ISO 13485, EU MDR and IVDR, FDA QSR, MDSAP, and Canadian regulations. Her expertise includes regulatory submissions, audit readiness, sterilization validation (EtO, Steam, Gamma), risk management, and hands-on training of multidisciplinary teams. Iris is a certified auditor, an SME reviewer for EU notified bodies, and a trusted advisor to companies seeking global market approval and sustainable regulatory excellence.