Alexandra Bouland

Alexandra Bouland is an experienced quality and regulatory affairs professional in the medical device sector, currently serving as CMO Quality Manager and Drug Delivery Devices Quality Manager at Merck Group since January 2018. Previous roles include QA/RA Manager at ALCIS, QA/RA Specialist at Sorin Group, RA Specialist at Mauna Kea Technologies, and QA/RA Manager at NORAKER. Expertise encompasses quality management systems (QMS) compliance, regulatory strategy development, and post-market surveillance for Class I to III medical devices, particularly in neurology and cardiology. Notable achievements include overseeing FDA and ANSM inspections, managing ISO certifications, and leading regulatory submissions across multiple global markets. Alexandra holds an engineering degree in Biomedical Engineering from ISIFC.