k
kendra_tabhitha

Kendra Tabhitha

@kendra_tabhitha

FDA Regulatory Affairs Consultant

United Kingdom
English, Russian
About me
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. ... Read more
k
kendra_tabhitha
Kendra Tabhitha
Offline • 
Average response time: 4 hours

See my services

Business Registration
I will products certification of medical devices for ce fda ukca mdr
From$15 / projectMore details
Medical Device Regulatory
I will medical devices eu mdr ivdr notified body compliance
From$50 / projectMore details

Work experience

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.