
Wisdom J
FDA Registration and Compliance Specialist
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Portfolio
Werkervaring
Regulatory Compliance Specialist
Freelancer.com
Apr 2026 - Present • 1 mo
Description: Provide regulatory compliance support to startups, manufacturers, and international businesses seeking entry into the U.S. market. Specialized in FDA registration, product listing, and compliance guidance for food, cosmetics, and medical devices. Assist clients with U.S. Agent representation, documentation, and submission processes to ensure accuracy and regulatory alignment. Also support SAM.gov registration and government contract readiness. Focus on simplifying complex requirements, preventing costly errors, and delivering reliable, confidential, and timely solutions tailored to client needs.
FDA Medical Device Listing Support for Startup Manufacturer
HealthCare.gov
Mar 2026 - Present • 2 mos
A medical device startup required assistance with FDA listing requirements before launching their product in the U.S. market. Their main concern was ensuring proper classification and compliance documentation to avoid regulatory delays. I provided structured guidance on FDA medical device listing requirements, helping the client organize their product classification details and prepare necessary submission data. I also supported them in understanding compliance pathways relevant to their device category. The project was successfully completed, giving the client a clear compliance roadmap and readiness for U.S. market entry.