k
kendra_tabhitha

Kendra Tabhitha

@kendra_tabhitha

FDA Regulatory Affairs Consultant

Reino Unido
Inglês, Russo
Algumas informações são exibidas no idioma inglês.
Sobre mim
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. ... Saiba mais
k
kendra_tabhitha
Kendra Tabhitha
offline • 
Tempo médio de resposta: 4 horas

Conheça meus serviços

Registro comercial
I will products certification of medical devices for ce fda ukca mdr
A partir deUS$ 15 /projetoMais detalhes
Regulamentação de dispositivos médicos
I will medical devices eu mdr ivdr notified body compliance
A partir deUS$ 50 /projetoMais detalhes

Experiência profissional

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.