
Ava A
FDA food labeling compliance
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Expérience professionnelle
Regulatory Affairs Assistant (FDA Registration Support)
Darek Regulatory Compliance Solutions
Jan 2026 - Present • 4 mos
Provide reliable support to businesses navigating FDA registration and U.S. regulatory compliance for food, drug, and medical device products. Assist clients with FDA establishment registration, product listings, and submission processes, ensuring accuracy and reducing the risk of delays or rejections. Help review documentation for completeness, consistency, and compliance, while supporting labeling checks, Prior Notice, and FSVP requirements. Guide clients through key FDA expectations with clear, step-by-step assistance tailored to first-time importers, startups, and growing brands. Offer ongoing support with U.S. Agent coordination, FEI number inquiries, and maintaining accurate records within FDA databases, helping businesses stay compliant and audit-ready. Work closely with small businesses and international sellers entering the U.S. market, providing practical guidance that simplifies complex regulatory processes and helps avoid common mistakes. Key Contributions: • Support FDA registration submissions and updates with improved accuracy • Help strengthen product listings and regulatory documentation • Provide step-by-step guidance for businesses entering the U.S. market • Support understanding and application of FDA compliance requirements