
JAME JOHANNA
FDA Compliance and Registration Consultant
Skills

Bekijk mijn diensten


Werkervaring
Medical Device Compliance Consultant
Addison Lee • Fulltime
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.