FDA-Compliant Workflow & SOP Specialist for Medical Device Distribution and Export (Short Project)

We are seeking an experienced professional to design compliant distribution workflows, develop audit-ready SOPs, and provide research-driven regulatory input aligned with FDA and U.S. export requirements. This is a focused, short-term project suited for someone with a proven regulatory and operational track record in pharmaceuticals or medical devices. What You’ll Do Build end-to-end compliant distribution workflows for medical devices. Create clear, implementation-ready SOPs covering storage, handling, traceability, documentation, complaints, and shipment/export controls. Ensure alignment with FDA Quality System Regulation (21 CFR Part 820), GDP principles, and record-keeping standards. Integrate U.S. export compliance considerations into operational procedures. Provide research-supported technical justification for regulatory and quality decisions. Identify process gaps, risks, and improvement opportunities. Ideal Candidate Background in Pharmacy, Medical Devices, Regulatory Affairs, Biomedical or related healthcare field. Hands-on experience with FDA compliance, QSR, GDP, ISO-style quality systems, or distribution SOP writing. Demonstrated ability to translate regulations and research into practical operational documents. Strong technical writing, regulatory interpretation, and documentation structuring skills. Proven track record in similar compliance or SOP projects. Project Deliverables Structured FDA-aligned distribution workflow. Complete set of audit-ready SOPs for distribution and export handling. Brief technical rationale with regulatory or scientific references. Potential for future regulatory and SOP development work based on performance.