o
oliveoritz3

Olive O

@oliveoritz3

FDA Registration, 510k, US Agent, Regulatory Expert

Estados Unidos
Inglés
Parte de la información aparece en idioma inglés.
Sobre mí
I am an FDA Regulatory Affairs Consultant specializing in FDA registration, U.S. Agent services, FDA 510(k), medical device compliance, MoCRA, NDC listing, food facility registration, FSVP, UDI/GUDID, FDA labeling, and import compliance. I help manufacturers, importers, Amazon sellers, startups, and international companies navigate complex FDA requirements with accurate documentation, regulatory strategy, and compliant submissions to support successful market entry into the United States.... Lee más

Habilidades

o
oliveoritz3
Olive O
desconectado • 
Tiempo medio de respuesta: 1 hora

Revisa mis servicios

Registro de negocios
I will fda registration import permit for food, drug cosmetics in USA, fda label review
DeUSD 15 / proyectoMás información
Registro de negocios
I will fda registration import permit for food, drug cosmetics in USA, fda label review
DeUSD 20 / proyectoMás información

Porfolio

Experiencia laboral

Medical_Group Care

Medical Device Regulatory Specialist

Medical Group Care • Freelance

May 2018 - Present • 8 yrs 3 mos

Supported medical device manufacturers with FDA regulatory strategy, FDA 510(k) submissions, device listing, UDI/GUDID registration, quality documentation review, labeling compliance, and regulatory gap assessments. Assisted clients in preparing submission-ready documentation while ensuring compliance with applicable FDA regulations.

John's_Workshop

Senior FDA Regulatory Affairs Consultant

John's Workshop • Freelance

Jan 2021 - Jul 2026 • 5 yrs 6 mos

Lead FDA regulatory projects for food, medical device, cosmetic, pharmaceutical, and dietary supplement manufacturers. Prepare FDA registrations, facility listings, FDA 510(k) documentation, U.S. Agent representation, MoCRA compliance, labeling reviews, import documentation, NDC listings, UDI/GUDID submissions, and regulatory strategies for domestic and international businesses seeking market access in the United States.

Food_and Agriculture Organization of the United Nations

FDA Food & Import Compliance Consultant

Food and Agriculture Organization of the United Nations • Freelance

Dec 2019 - Jul 2026 • 6 yrs 7 mos

Worked with food manufacturers, beverage companies, importers, exporters, and private label brands to complete FDA Food Facility Registration, Prior Notice submissions, FSVP compliance, FDA labeling reviews, U.S. Agent services, import documentation, and regulatory consulting to support successful entry into the U.S. market.