Regulatory Affairs/Quality Assurance
Ms. Aoife Donoghue is a Regulatory, Design Assurance and Quality Professional with over 20 years of multidisciplinary experience in the biopharmaceutical and medical device fields. She holds an MSc. in Biomedical Science and a BSc. in Pure and Applied Chemistry. She benefits from experience across the medical device and biopharmaceutical manufacturing industries. Aoife advises on all aspects of Regulatory Affairs, Clinical Affairs, Design Assurance and Quality System Management associated with US FDA, EU MDR to meet regulatory requirements including ISO13485, FDA QSR820 and MDR 2017/745. In her roles as Senior Design Assurance Engineer and QA/RA Manager for SME and MNCs including ArraVasc and Boston Scientific, Aoife has led research and engineering teams through regulatory compliance, risk management, design control and quality systems to achieve CE Mark and FDA510k clearance. Aoife has experience in various international standards including ISO14971, ISO10993, ISO14155, IEC62366, IEC60601 and IEC62304.