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Florian
@florian_53
ISO Compliance, Medical Device Regulatory, Food Safety Documentation Expert
Nigeria
Inglés
Sobre mí
I am a Regulatory Compliance and Quality Management Consultant specializing in ISO standards, medical device regulations, and food safety systems. I help organizations develop certification-ready documentation, implement compliant management systems, and navigate complex regulatory requirements with confidence. My expertise includes ISO 9001, ISO 13485, ISO 14001, ISO 45001, ISO 22000, ISO 27001, HACCP, GMP, FDA, CE Marking, MDR, QMS, SOPs, Technical Files, CERs, risk management, and audit readiness.
Habilidades
Florian
desconectado •
Tiempo medio de respuesta: 5 horas
Revisa mis servicios
Estrategia e innovación comercial
I will iso 9001, 27001, 14001, 45001, 22000, haccp, gmp certification and documentation
Escritura técnica
I will give authentic haccp plan, sops, gmp, iso 22000 food safety documentation
Porfolio
Experiencia laboral
Senior Regulatory Affairs Consultant
GHA Foundation • Freelance
Jan 2021 - Jul 2026 • 5 yrs 6 mos
Lead regulatory compliance projects for medical device manufacturers, healthcare organizations, and startups. Prepare Technical Documentation, Technical Files, Clinical Evaluation Reports (CER), Risk Management Files, FDA submissions, CE MDR documentation, ISO 13485 Quality Management Systems, and regulatory strategies. Support clients through product development, market access, certification readiness, and post-market compliance while ensuring alignment with global regulatory requirements.
ISO Management Systems Consultant
Juno Media • Freelance
May 2019 - Jul 2026 • 7 yrs 2 mos
Designed and implemented Quality Management Systems for organizations across manufacturing, healthcare, engineering, logistics, and technology sectors. Developed Quality Manuals, SOPs, Procedures, Risk Registers, CAPA, Internal Audit Programs, Management Review documentation, and certification-ready systems for ISO 9001, ISO 14001, ISO 45001, ISO 27001, ISO 22000, and Integrated Management Systems.
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This is my second project with Esmeralda, and once again she exceeded expectations! She handled my BOI report filing and compliance support quickly, professionally, and with great attention to detail. Her communication was excellent, the turnaround was very fast, and she made the entire process seamless....
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Esmeralda went above and beyond my expectations! She handled my LLC formation and EIN application with exceptional professionalism, accuracy, and speed. The turnaround was incredibly fast, communication was excellent, and she made the entire process smooth and stress-free. I highly recommend her services...
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