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LENA CHARLES
@lenacharles234
LENA PRO
Großbritannien
Englisch
Über mich
I'm Lena Charles, a Regulatory Compliance Expert in FDA, ISO & EU MDR. I help businesses achieve fast, stress-free compliance without delays or penalties. I handle FDA registration, import/export permits, eMDR, food & drug compliance, and supply chain support.
I also provide ISO 9001, 14001, 45001, 27001 & GMP documentation. For medical devices, I deliver CE marking, CER, ISO 13485 & technical files. Accurate, audit-ready, and reliable. Message me now to get compliant the right way. Thank you.
Kompetenzen
LENA CHARLES
offline •
Durchschnittliche Antwortzeit: 1 Stunde
Meine Dienstleistungen
Vorlagendokumente & Formatierung
I will act as mdr prrc eu mdr compliant technical documentation technical file ce 13485
Business-Strategien & -Innovation
I will iso 14001 iso 9001 iso 45001 certification complianc documentation iso 27001 gmp
Portfolio
Arbeitserfahrung
FDA & Regulatory Compliance Specialist
EY
Jan 2025 - Present • 1 yr 4 mos
I specialize in providing FDA regulatory support to both U.S. and international businesses across food, cosmetic, supplement, and medical device sectors. My work includes FDA registration, product listing, import/export permit guidance, and eMDR (electronic Medical Device Reporting) compliance. I assist clients in navigating FDA requirements, ensuring all submissions are accurate, complete, and aligned with regulatory standards. I also conduct detailed label reviews for food, supplements, and medical products, identifying compliance gaps and correcting them to meet FDA labeling regulations. Additionally, I support supply chain compliance by ensuring documentation, traceability, and regulatory alignment for smooth product entry into the U.S. market. I work closely with startups, Amazon sellers, and established companies to help them avoid costly delays, rejections, and compliance issues. My approach is detail-oriented, ensuring every aspect of regulatory submission is audit-ready and professionally handled.
