e
elizabethmercy4

Elizabeth mercy

@elizabethmercy4

FDA Regulatory Compliance Specialist 510k MoCRA FSVP and US Agent Services

États-Unis
Anglais, Espagnol, Français, Allemand, Italien, Danois, Grec, Estonien, Hébreu, Luxembourgeois, Romanche, Portugais, Chinois, Indonésien, Russe
Certaines informations sont présentées en anglais.
À propos de moi
I am Elizabeth Mercy a regulatory compliance specialist providing FDA regulatory services for medical devices, dietary supplements, cosmetics, and food products. I support full FDA 510(k) submissions, device listing, establishment registration, and US Agent representation for foreign manufacturers. I also provide MoCRA cosmetic compliance, product listing, labeling review, and documentation support. For food businesses, I assist with FSVP compliance. Amazon premarket submissions support.... Plus d’infos

Compétences

e
elizabethmercy4
Elizabeth mercy
hors ligne • 
Temps de réponse moyen de 1 heure

Voir mes services

Consultation produits
I will do fda 510k submission,device listing and US agent fda amazon premarket submiss
De30 $US / projetPlus de détails
Consultation produits
I will handle fda cosmetic registration, mocra compliance, and product listing
De30 $US / projetPlus de détails

Expérience professionnelle

FDA Regulatory Affairs Specialist

Business • Freelance

Mar 2026 - Present • 2 mos

As an FDA Regulatory Affairs Specialist, I manage FDA 510k submission, FDA registration, and medical device compliance for startups, manufacturers, and Amazon sellers entering the US market. I have successfully guided multiple clients through premarket submissions, ensuring accurate documentation and regulatory alignment. My responsibilities include device classification, FDA device listing, US agent coordination, and NDC registration. I work closely with clients to prepare complete, error-free submissions that reduce delays and improve approval success rates. I have helped businesses avoid costly FDA rejections, compliance penalties, and Amazon listing issues by providing clear, strategic regulatory guidance. My focus is on fast turnaround, compliance accuracy, and delivering results that support product approval and market entry.