Biomedical engineer specializing in regulatory compliance, quality assurance, and post-market surveillance for medical devices, ensuring full adherence to EU MDR and FDA standards. Proven track record in managing design control processes per FDA 21 CFR 820.30 and implementing ISO 13485 quality management systems, resulting in a 20% reduction in audit findings. Adept at leading cross-functional teams through regulatory submissions and continuous improvement initiatives, driving product safety and market success.