Regulatory Affairs Specialist
CurrentMedical device and tissue bank regulatory affairs. FDA 21 CFR 803, 806, 1271, AATB, ISO 13485: 2016 + MDSAP regulatory compliance. Complaint Coordinator, Internal Audits, QC inspection, Creation and submission of FDA MedWatch, EU Vigilance Reports, and maintenance of corporate federal and state licensing. Domestic and foreign medical device product.