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elizabethmercy4

Elizabeth mercy

@elizabethmercy4

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

Estados Unidos
Inglês, Espanhol, Francês, Alemão, Italiano, Dinamarquês, Grego, Estoniano, Hebraico, Luxemburguês, Romanche, Português, Chinês, Indonésio, Russo
Algumas informações são exibidas no idioma inglês.
Sobre mim
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.... Saiba mais

Habilidades

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elizabethmercy4
Elizabeth mercy
offline • 
Tempo médio de resposta: 1 hora

Conheça meus serviços

Consultoria de produtos
I will do fda 510k submission,device listing and US agent fda amazon premarket submiss
A partir deUS$ 30 /projetoMais detalhes
Consultoria de produtos
I will handle fda cosmetic registration, mocra compliance, and product listing
A partir deUS$ 30 /projetoMais detalhes

Experiência profissional

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.