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Williams W
@williams_wiln
FDA Regulatory Affairs Consultant
Großbritannien
Englisch
Über mich
I am a detail-oriented regulatory affairs consultant specializing in FDA compliance for cosmetics, food, OTC products, and medical devices. I have extensive experience in MoCRA compliance, facility registration, and product listing for businesses entering the U.S. market.
Kompetenzen
Williams W
offline •
Durchschnittliche Antwortzeit: 1 Stunde
Meine Dienstleistungen
Gewerbeanmeldung
I will do fda food facility registration prior notice and fsvp support
Gewerbeanmeldung
I will do fda medical device registration, device listing and fda compliance
Portfolio
Arbeitserfahrung
Senior Regulatory Compliance Specialist | Regulatory Consult Partners
Business • Vollzeit
Apr 2023 - Present • 3 yrs 4 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.
