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Ben
@ben9888
Fast and Reliable FDA 510k Device Listing and Compliance Expert
Royaume-Uni
Anglais, Espagnol, Allemand
À propos de moi
I am a regulatory compliance specialist with expertise in FDA 510(k) submissions, device listing, NDC registration, and full FDA compliance support. I help medical device and healthcare companies navigate complex regulatory requirements with accuracy and efficiency. My services are detail-oriented, reliable, and designed to ensure smooth approval and registration processes. I am committed to delivering compliant, well-prepared submissions that meet FDA standards and support your product’s successful market entry.
Compétences
Ben
hors ligne •
Voir mes services
Gestion de projet
I will handle fda 510k submission, device listing, ndc, fda registration compliance
Traduction
I will do fda cosmetic registration, mocra compliance, US agent support
Expérience professionnelle
FDA Regulatory Compliance Specialist
Independent Reserve • Freelance
Jan 2022 - Present • 4 yrs 4 mos
FDA Regulatory Compliance Specialist with extensive hands-on experience in preparing and managing FDA 510(k) submissions, medical device listings, NDC registration, and establishment registration. I have supported startups, manufacturers, and healthcare companies in ensuring full FDA compliance for successful U.S. market entry. Skilled in compiling technical documentation, regulatory strategy, and submission support, I ensure accurate, timely, and compliant filings aligned with FDA requirements.
