FDA Regulatory Compliance and Product Specialist Support

The contract provides regulatory support for FDA Class I medical devices, encompassing registration with the FDA, compliance with labeling requirements, adherence to Good Manufacturing Practices, and coordination with EBS product specialists to ensure seamless regulatory alignment. The scope is focused on maintaining compliance with U.S. regulatory standards through ongoing administrative and operational support tailored to the unique requirements of Class I medical devices, which are typically low-risk but still subject to strict documentation and oversight. This subcontract, issued under the Defense Logistics Agency within the Department of Defense, is identified by the NAICS code 541611 and is linked to contract SPE2DS26P2479. It was posted on July 16, 2026, and is structured to support federal regulatory functions related to medical device lifecycle management. While specific performance locations and point of contact details are not provided, the work is presumed to be performed in alignment with DLA’s operational and compliance objectives, ensuring that medical devices meet all applicable FDA mandates and internal defense logistics protocols.