Medical Device Regulatory Consultant

Medical Device Regulatory Consultant Medical-device regulatory compliance consultant with direct, repeat experience supporting IDE sponsors with investigational-device exports and imports under 21 CFR 812.18.Must have personally developed and implemented the associated SOPs, work instructions, forms, decision trees and shipment-release controls. Experience preparing FDA export-authorization requests under Section 801(e), determining applicability of Section 802 pathways, supporting BIMO/483 CAPA remediation, and addressing Taiwan and Australian import requirements is strongly preferred. Contract opportunity, 40 hrs per week for 3-4 weeks, then ongoing Ad-Hoc support Fully Remote Working