Regulatory and Compliance Support for Medical Procurement

This contract provides regulatory and compliance support specifically tailored to urgent medical procurement activities under FAR 6.302-2, focusing on the preparation and maintenance of FDA compliance documentation and sole-source justifications. The work ensures that time-sensitive medical supplies and equipment can be acquired without delay while adhering to federal acquisition regulations and health safety standards. The contractor will be responsible for navigating complex regulatory landscapes to justify sole-source procurement decisions, document FDA-related requirements, and maintain audit-ready records to support mission-critical healthcare operations. The contract is classified as a subcontract under NAICS code 541611, indicating it involves administrative management and general management consulting services, and is performed on behalf of the Defense Health Agency, a component of the Department of Defense. Performance is centered at Camp Lejeune, North Carolina, with the primary objective of enabling rapid procurement of medical resources necessary for military healthcare readiness. The work demands a deep understanding of both federal acquisition rules and healthcare regulatory frameworks, ensuring that all documentation meets stringent compliance standards while preserving operational urgency and accountability.