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Lemond Lei
@lemondlei
Medical Device Regulatory, ISO QMS and Compliance Expert
Chine
Chinois
À propos de moi
I am a compliance specialist supporting overseas importers sourcing general consumer goods, medical devices and OTC drugs from China.
I have 30 years of quality management experience, 15 years focused on medical devices and OTC pharmaceuticals.
Core services: supplier qualification verification & regulatory compliance review. I help importers assess supplier compliance risks (qualification certification verification), review QMS, QSR, GMP and medical device labels, conduct sample and product inspections.
My expertise covers ISO 9001, ISO 13485, FDA 21 CFR Part 820/210/211, and Canada CMDR.
Compétences
Lemond Lei
hors ligne •
Temps de réponse moyen de 1 heure
Voir mes services
Sécurité des produits et certification de la qualité
I will support overseas importers sourcing medical device otc drug and general goods
Portfolio
Expérience professionnelle
Independent Compliance & Quality Consultant
Compliant Medical Billing and Consulting • Indépendant
Jun 2026 - Present • 3 mos
Support overseas importers sourcing consumer goods, medical devices and OTC pharmaceuticals from China. Provide supplier compliance risk assessment, QMS/QSR/GMP document review, medical device label review, sample & product inspection, and regulatory audit assistance and tutoring.
Management Representative & Quality Compliance Director
Medical • Temps plein
Oct 2011 - Jun 2026 • 14 yrs 8 mos
Served as Management Representative, in charge of quality & compliance for medical devices and OTC pharmaceuticals. Managed QMS, QSR and GMP systems, supplier audits, label reviews, risk assessment and product inspections.
Quality Management Manager
Enterprise • Temps plein
Jun 1996 - Sep 2011 • 15 yrs 3 mos
Established ISO 9001 quality systems, monitored QA/QC activities, conducted supplier evaluation and quality improvement (CAPA) for manufacturing products.
