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leoldah

Leoldah

@leoldah

FDA Compliance Expert ,Registration, Listing

Estados Unidos
Inglês
Algumas informações são exibidas no idioma inglês.
Sobre mim
Hi, I'm leoldah, your Regulatory Affairs Expert for full-spectrum FDA compliance. I specialize in facility registration, US Agent services, label reviews, and listings for medical devices, food, drugs, supplements, and cosmetics. From 510(k) and QMS to cGMP and import guidance, I navigate the complex rules blocking your US market entry. Avoid fines and holds with my audit-ready, precision-driven solutions. Message me now for seamless, worry-free FDA compliance.... Saiba mais

Habilidades

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leoldah
Leoldah
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Tempo médio de resposta: 1 hora

Conheça meus serviços

Registro comercial
I will handle fda food, drug, and device registration fast
A partir deUS$ 30 /projetoMais detalhes
Registro comercial
I will handle your ttb registration and alcohol import compliance
A partir deUS$ 15 /projetoMais detalhes

Experiência profissional

Senior Regulatory Affairs & QMS Consultant | EU MDR, FDA 510(k), ISO 13485

MDB Consulting Agency • Freelance

Feb 2025 - Present • 1 yr 6 mos

Regulatory Affairs & QMS Consultant with 6+ years of experience supporting clients across medical devices, IVDs, cosmetics, food, and pharmaceuticals. Specialized in EU MDR, UKCA, and FDA compliance, including 510(k) submissions and FDA Establishment Registration. Key achievements include preparation of Technical Documentation/Technical Files, development of ISO 13485 QMS documentation, and execution of risk management (ISO 14971), CER, and IFU compliance. Conducted gap assessments, internal audits, and provided practical regulatory strategies to ensure audit readiness and efficient market access. Focused on delivering clear, compliant, and actionable solutions tailored to client needs.