Medical Device Regulatory Consultant
ProPharma
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
Vacancy posted 3 days ago
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