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JAME JOHANNA
@james_juhanna
FDA Compliance and Registration Consultant
Nigeria
Inglese, Francese
Chi sono
Hello and Welcome. I’m Jame Johanna, a highly recommended expert in FDA 510(k) submissions, FDA registration, medical device listing, NDC registration, GUDID listing, DUNS/UFI registration, U.S. Agent services, and regulatory documentation. I help manufacturers, importers, and brand owners navigate U.S. FDA requirements with accurate documentation, practical guidance, and reliable regulatory support. My focus is simplifying complex compliance processes, and helping you move forward with confidence. Let’s get your FDA compliance process on the right track. SEND A DM TO ORDER NOW.
Competenze
JAME JOHANNA
offline •
Tempo di risposta medio: 4 ore
Consulta i miei servizi
Gestione progetti
I will assist with fda 510k, ndc registration, and regulatory compliance
Consulenze prodotti
I will handle fda cosmetic registration and mocra compliance
Esperienza lavorativa
Medical Device Compliance Consultant
Addison Lee • Full time
Jul 2026 - Present • 2 mos
Assisted businesses with U.S. medical device compliance requirements, regulatory documentation, device listing, and FDA submission preparation. Achievements: Helped clients better understand FDA medical device requirements. Reviewed documentation for completeness and consistency. Supported smoother preparation of regulatory submissions.
FDA Regulatory & Compliance Specialist
Juliana Kennedy CPA • Freelance
May 2026 - Present • 4 mos
Help clients understand complex U.S. regulatory requirements and identify potential compliance gaps. Deliver structured, detail-oriented support designed to minimize documentation errors, delays, and compliance risks.
FDA Regulatory & Compliance Specialist
The ActiveSeat Co. • Freelance
Apr 2025 - Present • 1 yr 5 mos
- Support manufacturers, importers, and brand owners with FDA registration and regulatory requirements. - Assist with FDA 510(k), medical device listing, GUDID, NDC registration, U.S. Agent services, and regulatory documentation. - Review documentation for accuracy, completeness, and regulatory consistency. - Help clients understand complex compliance requirements and prepare for regulatory submissions.
