
Grace Coleman
FDA Regulatory Consultant, FDA Registration, 510k Submissions, Compliance Expert
Skills

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Werkervaring
Senior FDA Regulatory Compliance Consultant
Redefine Meat • Freelance
Jan 2021 - Aug 2024 • 3 yrs 7 mos
Provided end-to-end FDA regulatory consulting services for manufacturers, startups, and international businesses entering the U.S. market. Managed FDA Establishment Registration, Device Listing, 510(k) submissions, U.S. Agent services, import permits, label compliance reviews, and regulatory documentation. Assisted clients in meeting FDA requirements efficiently while reducing compliance risks and avoiding costly delays. Successfully supported multiple product launches across medical devices, dietary supplements, cosmetics, and food sectors
FDA Compliance Website & eCommerce Specialist
Tech Hub • Freelance
Nov 2020 - Jul 2023 • 2 yrs 8 mos
Designed and developed FDA-focused websites for peptide, supplement, cosmetic, and health-related businesses using WordPress and WooCommerce. Created compliant product pages, implemented regulatory-friendly content structures, optimized user experience, and integrated eCommerce functionality. Collaborated with business owners to ensure websites aligned with industry regulations while maintaining strong branding, conversion rates, and professional online presence.