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williams_wiln

Williams W

@williams_wiln

FDA Regulatory Affairs Consultant

Royaume-Uni
Anglais
Certaines informations sont présentées en anglais.
À propos de moi
Hello and welcome, I’m Williams, an all-time FDA Regulatory Affairs Strategist helping businesses navigate FDA registration, compliance, and market-entry requirements with clarity and confidence. With strong client recommendations, I combine regulatory strategy, attention to detail, and practical guidance to simplify complex FDA processes. My services include FDA registration, MoCRA compliance, 510(k) submissions, FDA product listing, U.S. Agent , FDA label review, and related regulatory support. Need help with an FDA requirement or market entry? Send me a DM now, I’m just a message away.... Plus d’infos

Compétences

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williams_wiln
Williams W
hors ligne • 
Temps de réponse moyen de 1 heure

Voir mes services

Immatriculation d'entreprise
I will do fda food facility registration prior notice fsvp support fda import permit
De20 $US / projetPlus de détails
Immatriculation d'entreprise
I will do fda medical device registration, device listing and fda compliance
De10 $US / projetPlus de détails

Portfolio

Expérience professionnelle

RegulaCore

Manager

RegulaCore • Temps partiel

Dec 2024 - Present • 1 yr 10 mos

Supported clients with FDA registration, product listing, U.S. Agent services, MoCRA compliance, 510(k) submissions, and FDA label reviews. Provided practical regulatory guidance and detail-focused support to help businesses navigate U.S. market-entry requirements.

Senior Regulatory Compliance Specialist | Regulatory Consult Partners

Business • Temps plein

Apr 2023 - Nov 2024 • 1 yr 7 mos

Successfully managed end-to-end FDA cosmetic registration and mandatory MoCRA compliance portfolios for over 150+ domestic and international beauty brands. Served as the designated US Agent service representative for foreign manufacturing facilities, acting as the primary legal liaison for all official communications with the US Food and Drug Administration. Established an error-free protocol for acquiring FEI numbers (FDA Establishment Identifier) and configuring user accounts securely on the Cosmetics Direct portal and CDX network. Handled complex OTC registration frameworks, ensuring full compliance for over-the-counter drug products including sunscreens, acne treatments, and hand sanitizers through precise ingredient list and SPL submissions. Spearheaded corporate audits for safety review substantiation, ensuring client packaging, product labeling, and adverse event reporting processes aligned perfectly with federal mandates to eliminate the risk of customs holds.