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florian_53

Florian

@florian_53
5,0(2)

ISO Compliance, Medical Device Regulatory, Food Safety Documentation Expert

Nigeria
Inglese
Alcune informazioni sono riportate in lingua inglese.
Chi sono
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.... Continua a leggere

Competenze

f
florian_53
Florian
offline • 
Tempo di risposta medio: 6 ore

Consulta i miei servizi

Strategia di business e innovazione
I will iso 9001, 14001, 45001, 27001, 22000, haccp, gmp iaf certification documentation
5,0(2)
Scrittura tecnica
I will give authentic haccp plan, sops, gmp, iso 22000 food safety documentation

Portfolio

Esperienza lavorativa

GHA_Foundation

Senior Regulatory Affairs Consultant

GHA Foundation • Freelance

Jan 2021 - Jul 20265 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.

Juno_Media

ISO Management Systems Consultant

Juno Media • Freelance

May 2019 - Jul 20267 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.

2 Recensioni
5,0

(2)
(0)
(0)
(0)
(0)
Valutazione dettagliata
  • Livello di comunicazione del venditore
    5
  • Qualità della consegna
    5
  • Valore della consegna
    5
1-2 di 2 recensioni
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    M
    image-docs

    macleender

    Cliente abituale

    US

    Stati Uniti

    5

    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....

    Fino a 50 USD

    $

    3 giorni

    Tempo

    gig

    Strategia di business e innovazione

    Utile?
    No
    M
    image-docs

    macleender

    Cliente abituale

    US

    Stati Uniti

    5

    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...

    Fino a 50 USD

    $

    3 giorni

    Tempo

    gig

    Strategia di business e innovazione

    Utile?
    No