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Olive O
@oliveoritz3
FDA Registration, 510k, US Agent, Regulatory Expert
États-Unis
Anglais
À propos de moi
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.
Compétences
Olive O
hors ligne •
Temps de réponse moyen de 1 heure
Voir mes services
Immatriculation d'entreprise
I will fda registration import permit for food, drug cosmetics in USA, fda label review
Immatriculation d'entreprise
I will fda registration import permit for food, drug cosmetics in USA, fda label review
Portfolio
Expérience professionnelle
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.
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.
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.
