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Greg Greg
@greggregfda
ISO, Regulatory Affairs FDA, EU, UK, PMN 510k, QMS and Professionalism
Royaume-Uni
Anglais, Français, Allemand
À propos de moi
Medical Device Regulatory & ISO Compliance Expert with 20+ years of experience helping businesses meet global compliance standards. Specialized in ISO 13485, ISO 9001, FDA regulations, MDR 2017/745, MDD 93/42/EEC, cGMP, risk management, QMS documentation, and technical file preparation. IRCA Approved Lead Auditor providing professional support for medical device compliance, regulatory affairs, audits, SOPs, CAPA, and quality management systems. Focused on accuracy, reliability, confidentiality, and helping clients achieve smooth certification and compliance success.
Compétences
Greg Greg
hors ligne •
Voir mes services
Gestion de projet
I will do fda registration and 510k dossier, 21 cfr 820 I cgmp
Gestion de projet
I will give iso 9001, 45001 14001, gmp, 22301, iso certification
Expérience professionnelle
Medical Device Regulatory Affairs & ISO Compliance Consultant
Salvatore Ferragamo • Freelance
Mar 2021 - Present • 5 yrs 2 mos
Provided regulatory affairs, ISO compliance, and quality management system support for medical device manufacturers and healthcare businesses. Assisted clients with ISO 13485, ISO 9001, FDA compliance, MDR 2017/745, MDD 93/42/EEC, cGMP, risk management, SOP development, CAPA, technical documentation, internal audits, and quality system implementation. Supported companies in achieving regulatory compliance, improving operational processes, preparing technical files, and maintaining international quality standards for medical device certification and market access.
