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FDA Regulatory & Compliance Specialist
UL
Jan 2026 - Mar 2026 • 2 mos
I specialize in end-to-end FDA compliance services for food, dietary supplements, cosmetics, medical devices, and OTC products. I help manufacturers, importers, startups, and Amazon sellers navigate FDA regulations and meet U.S. market entry requirements with confidence and accuracy. My work includes detailed FDA label reviews for food, supplement, and medical products. I assess product labels for compliance with FDA regulations, including ingredient declarations, nutrition and supplement facts panels, allergen statements, claims review, and proper formatting. I identify non-compliant claims, misleading statements, and labeling gaps to help clients avoid regulatory actions and market delays. I manage FDA registration and product listing for both domestic and foreign companies, ensuring proper establishment registration, product classification, and submission accuracy. I also support clients with FDA 510(k) submissions for medical devices, including device classification, regulatory pathway analysis, and technical documentation preparation. Additionally, I assist with device listing, establishment registration, and ongoing FDA compliance obligations. I support OTC and drug-related compliance, including NDC registration and labeling compliance. My services also include acting as an FDA US Agent for non-U.S. companies, managing regulatory communications, and ensuring foreign facilities meet FDA requirements for U.S. market entry. Beyond registration and submissions, I help businesses implement compliance strategies across their supply chain and product lifecycle, reducing risk and ensuring ongoing regulatory alignment. I work closely with clients to resolve compliance challenges, respond to regulatory concerns, and prepare audit-ready documentation. My focus is accuracy, compliance, and smooth market access, helping clients avoid delays, costly mistakes, and enforcement actions while confidently entering or expanding in the U.S. market.