Emeric Gaffiero is a seasoned professional in quality assurance and regulatory affairs, currently serving as Senior Manager of External Manufacturing Quality at Santen since September 2017. With extensive experience in the medical devices sector, Gaffiero has managed critical aspects of the Quality Management System (QMS), ensuring CE mark certification and overseeing complaint handling, deviations, CAPAs, and change control through Trackwise. Previous roles include Quality and Regulatory Affairs Manager at Suricog, where Gaffiero established the QMS, achieving ISO certifications, and earlier positions at Aptar Stelmi and SOFIBEL where contributions included system redesign and quality indicator implementation. Gaffiero holds multiple degrees, culminating in a Master 2 in Medical Device Regulation from the University of Strasbourg and has participated in various internal and external audits, trainings, and regulatory intelligence initiatives.
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