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Kendra Tabhitha
@kendra_tabhitha
FDA Regulatory Affairs Consultant
Großbritannien
Englisch, Russisch
Über mich
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.
Kendra Tabhitha
offline •
Durchschnittliche Antwortzeit: 4 Stunden
Meine Dienstleistungen
Gewerbeanmeldung
I will products certification of medical devices for ce fda ukca mdr
Regulierung für Medizinprodukte
I will medical devices eu mdr ivdr notified body compliance
Arbeitserfahrung
Contract Regulatory Affairs Consultant (Freelance)
ClearPath Medical Regulatory Solutions, Inc • Freiberufler
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.
