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kendra_tabhitha

Kendra Tabhitha

@kendra_tabhitha

FDA Regulatory Affairs Consultant

Verenigd Koninkrijk
Engels, Russisch
Sommige informatie wordt in het Engels weergegeven.
Over mij
Hello and welcome. I’m a Regulatory Compliance Consultant with more than 7 years of professional experience in FDA regulatory affairs, I help manufacturers navigate complex FDA requirements with clarity and confidence. My services cover 510(k) submissions, UDI and GUDID setup, Establishment Registration, Device Listing, and ongoing compliance support ensuring your products remain legally registered and market ready in the United States. ... Lees meer
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kendra_tabhitha
Kendra Tabhitha
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Gemiddelde reactietijd: 4 uur

Bekijk mijn diensten

Bedrijfsregistratie
I will products certification of medical devices for ce fda ukca mdr
VanafUS$ 15 / projectMeer informatie
Regelgeving voor medische hulpmiddelen
I will medical devices eu mdr ivdr notified body compliance
VanafUS$ 50 / projectMeer informatie

Werkervaring

Contract Regulatory Affairs Consultant (Freelance)

ClearPath Medical Regulatory Solutions, Inc • Freelance

Jul 2022 - Apr 2025 • 2 yrs 9 mos

Worked as a contracted Regulatory Affairs Consultant providing FDA compliance support to medical device manufacturers entering the U.S. market. Collaborated with cross-functional teams to manage Establishment Registration, Device Listing, and 510(k) premarket notification documentation for Class I and Class II medical devices.