Josef Komarek

Experience

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  Randox

  Jun 2006 - Feb 2007

  Sales Manager

  Sales Manager for In-vitro diagnostic products in Czech and Slovak Republic

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  Bioveta, a. s.

  Feb 2007 - Nov 2008

  Head of rabies vaccine production department

  Responsibility for a team of 40 colleagues, creating almost 20% of company revenue (after 11 months already, without any previous managerial experience) Characteristic of work: Aseptic production, Biotechnology, Validations, Qualifications, Innovations, Sterilizations, Cell Culture growing, Inactivation, Bulk Formulation, New Clean room getting to work, all acc. to GMP standards. Production of Bioveta own products as well as OEM manufacturing – e.g. for Pfizer, Bayer, Riemser, Aceto.

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  Meomed s.r.o.

  Dec 2008 - Feb 2022

  Meomed (joint venture of Siemens Healthineers and Meopta-optika): a manufacturer of X-ray image intensifiers and detectors (medical devices, NDT) and subassemblies for IVD analysers Responsibility for the whole Quality Management System - Quality Policy, Goals, Monitoring, Auditing (internal, supplier audits), Regulatory Affairs (incl. Technical file, Clinical evaluation, NB and authorities communication - SUKL, TÜV, UL), Change Management, Validations, Documentation, Quality Agreements, Testing, Metrology, Improvement, Compliance and many others. Show less

  • Quality Director

    May 2009 - Feb 2022

  • Head of Quality Assurance

    Dec 2008 - Apr 2009
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  Meopta - optika, s.r.o.

  Sept 2019 - Feb 2020

  Project coordinator

  Responsibility for ISO 13485 implementation (for ca. 200 out of 2500 employees)

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  NQA Czech Republic

  Oct 2020 - now

  Auditor ISO 13485 and ISO 9001, QMS Expert

  Lead auditor ISO 13485 and ISO 9001Expert for ISO 13485, GAP analysis, Quality Management System

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  Czech metrology Institute

  Dec 2020 - now

  Lecturer, Lead auditor

  Notified Body / Certification Body for Medical Devices 2020-2022 Lead auditor 2022-now Lecturer

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  Živnostník

  Mar 2021 - now

  Consultant & Auditor for Medical Devices - freelancer

  SERVICE PROVIDED:Quality Management System implementation (acc. ISO 13485, GxP, ISO 9001)Regulatory support - (Technical documentation, incl. Risk Management, Clinical evaluation, PMS/PMCF, UDI, notified body communication etc.)Auditing - internal audits, key supplier auditsLecturer (ISO 13485, ISO 9001, ISO 14971, ISO 19011, Medical Device Regulation 2017/745)Process optimalizationEXPERIENCE:Medical devices: APAG Cosyst (GAP analysis for subsidiaries in CZ, DE, CH, CA)BioHealing – device utilizing tissues of human origin (class III); Aireen – SW as Medical device (AI, class IIb); SCase – combined diagnostic device (class IIb); ALPS – prosthetics; Faveo Healthcare – textile products; Hilbi – SW as medical device; easyMed (distributor) …and othersGMP: PASTEUR – Filiala Filipesti SA, Romania (Farmavet Group) Show less

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  Aireen

  Mar 2021 - now

  PRRC & Consultant (quality and regulatory)

  Artificial intelligence based Eye fundus diagnostics - class IIb medical devices

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  BioHealing s.r.o.

  Jun 2022 - now

  PRRC & Consultant (quality and regulatory)

  Perinatal tissue derived products for advanced treatment - class III medical devices