High‐performing, results-oriented quality and regulatory professional with more than thirty years of experience in the medical device sector.Experienced at implementing and managing effective and efficient quality management systems with a proven track record of positive regulatory audits and inspections.Well-versed supporting the full product life-cycle from the needs identification/requirements gathering phase to the commercialization/post-market phase, including design assurance, regulatory submissions, risk management, supplier management, operations quality and quality management systems.
Listed skills include Medical Devices, Quality System, Iso 13485, Fda, and 26 others.