l
leoldah

Leoldah

@leoldah

FDA Compliance Expert ,Registration, Listing

États-Unis
Anglais
Certaines informations sont présentées en anglais.
À propos de moi
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.... Plus d’infos

Compétences

l
leoldah
Leoldah
hors ligne • 
Temps de réponse moyen de 1 heure

Voir mes services

Immatriculation d'entreprise
I will handle fda food, drug, and device registration fast
De30 $US / projetPlus de détails
Immatriculation d'entreprise
I will handle your ttb registration and alcohol import compliance
De15 $US / projetPlus de détails

Expérience professionnelle

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.