Samuel G

Regulatory Affairs Assistant (FDA Registration Support)

Darek Regulatory Compliance Solutions • Freiberufler

Feb 2022 - Dec 2025 • 3 yrs 10 mos

Provide practical support to businesses navigating FDA registration and basic regulatory compliance requirements for food, drug, and medical device products in the U.S. Assist clients with FDA registration processes, establishment registration, and product listing guidance. Help review documentation for completeness, support labeling compliance checks, and guide clients on requirements such as Prior Notice and FSVP. Offer general assistance with U.S. Agent coordination, FEI number inquiries, and maintaining accurate information in FDA databases. Work primarily with small businesses, startups, and first-time importers who need clear and reliable guidance to avoid common mistakes and delays during the FDA registration process. Key Contributions: • Assisted clients with FDA registration submissions and updates • Helped improve accuracy of product listings and documentation • Provided step-by-step guidance for new businesses entering the U.S. market • Supported compliance understanding for FDA requirements