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Zakir H.
@zakir_canada
Regulatory Affairs Specialist
Paquistão
Inglês
Sobre mim
I’m Zakir, a MedTech Regulatory Specialist and ISO Lead Auditor with 10+ years of experience. Based in Canada, I specialize in EU MDR (2017/745) and IVDR compliance for Class I through Class III medical devices.
I help manufacturers navigate the complex path to CE Marking by delivering audit-ready Technical Files (STED), CERs, Risk Management (ISO 14971), and PMS/PMCF documentation. My unique perspective as an auditor ensures your documentation is structured to pass Notified Body reviews with zero friction. Let’s secure your market clearance.
Habilidades
Zakir H.
offline •
Tempo médio de resposta: 1 hora
Conheça meus serviços
Redação Técnica
I will provide eu mdr 2017 technical documentation
Regulamentação de dispositivos médicos
I will build an iso 13485 qmsr quality management system for the medical device
Portfólio
Experiência profissional
Freelance Regulatory Documentation Specialist
Independent Consultant
May 2024 - Feb 2025 • 9 mos
Delivered freelance regulatory documentation services for startups and SMEs. Developed technical documentation, risk management reports, and clinical documentation in line with EU MDR and ISO standards. Focused on clear, structured, and compliant regulatory deliverables.
Regulatory Affairs Specialist
Medical Device Regulatory Consultancy
Mar 2023 - Feb 2024 • 11 mos
Provided regulatory consulting and documentation support for medical device manufacturers. Assisted in EU MDR transition projects, documentation remediation, and alignment with harmonised standards. Collaborated with cross-functional teams to ensure audit-ready submissions.
Regulatory Affairs Specialist
Pharma Consultancy
Jan 2020 - Apr 2022 • 2 yrs 3 mos
Worked on EU MDR (2017/745)–compliant technical documentation for Class I–III medical devices. Prepared and reviewed Technical Files, Design Dossiers, CERs, Risk Management files (ISO 14971), PMS/PMCF plans, IFUs, and labeling. Supported regulatory gap analyses and conformity assessment readiness for EU market access.
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zevsek
Eslovênia
Very professional service provider. He delivered technical documentation that exceeded my expectations. I will definitely hire him again.
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