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Kendra Tabhitha
@kendra_tabhitha
Your Trusted Partner for Regulatory Compliance and Quality Management
Verenigd Koninkrijk
Engels, Russisch
Over mij
I am a Regulatory Compliance and Quality Management Specialist with over 4 years of experience helping businesses achieve ISO certification, medical device compliance, and regulatory readiness. I specialize in ISO standards, MDR, ISO 13485, IEC 60601, compliance documentation, audit support, and quality management systems. My focus is delivering accurate, professional, and results-driven solutions that help organizations meet regulatory requirements with confidence.
Kendra Tabhitha
offline •
Gemiddelde reactietijd: 4 uur
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Bedrijfsregistratie
I will products certification of medical devices for ce fda ukca mdr
Regelgeving voor medische hulpmiddelen
I will mdr iso 13485 iec 60601 medical device compliance and documentation
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.
