Pavla Buček Klejchová

Regulatory Affairs Manager at MEDICEM
  • Claim this Profile
Contact Information
us****@****om
(386) 825-5501
Location
Prague, Czechia, CZ

Topline Score

Topline score feature will be out soon.

Bio

Generated by
Topline AI

You need to have a working account to view this content.
Join now
You need to have a working account to view this content.
Join now

Credentials

  • Regulatory Affairs Certificate: Medical Devices
    Regulatory Affairs Certification Program
    May, 2023
    - Nov, 2024
  • RAPS Member
    Regulatory Affairs Certification Program
    Sep, 2022
    - Nov, 2024

Experience

  • MEDICEM
    • Czechia
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs Manager
      • Jan 2023 - Present

      - Regulatory submissions worldwide- Certification & Recertification of medical devices (MDD, MDR, UKCA) and quality management system (ISO 13485, MDSAP)- Technical documentation / medical device file submissions- Instructions for use and labelling- Internal auditor (ISO 13485 & MDSAP)- Risk management (ISO 14971)- Complaints handling, vigilance reporting and FSCA (including recalls)- Clinical evaluation, PMS, PMCF

    • Regulatory Affairs Specialist
      • Mar 2018 - Dec 2022

      - Coordination of regulatory activities and registration/notification of medical devices worldwide- Negotiation with national competent authorities and the notified body- Compiling and updating the technical documentation / medical device file- Reimbursement and pricing in the Czech Republic- Instructions for use and labelling- ISO 13485 auditor- Monitoring of legislation and technical standards, identifications of GAPs- Risk management activities- Complaints handling, vigilance reporting and FSCA (including recalls)- Cooperation on PMS, PMCF and clinical evaluation Show less

  • Military Technical Institute, s.e.
    • Prague
    • Research & Development Specialist – Biomedical engineering
      • Aug 2017 - Feb 2018

      - Signal Analysis (ECG, EEG, eye tracking, speech analysis) - Data-mining - Simulation and system modeling - Evaluation of physiological reactions in situation with high mental load - Correlation between physiological reactions and psychological tests - Evaluating the reactions under communication and information load - Data collection and processing - Monitoring of state-of-the-art trends and procedures in biomedical applications all around the world - Preparation of research documents and expert statements - Participation on tender process and opposition procedures - Expert consultancy Show less

  • B. Braun Medical Inc. (US)
    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Regulatory Affairs Specialist (Registration and reimbursement)
      • Oct 2013 - Jul 2017

      - Coordination of regulatory submissions and necessary documentation for registration/notification of medical devices, biocidal products, cosmetics, food for special medical purposes and dietary supplement - Reimbursement of medical devices and food for special medical purposes in the Czech Republic - Review of instructions for use and labeling to be in compliance with applicable regulations - Compiling and maintaining safety data sheets database - Identification of relevant legislation or international standards - Supportive auditor in internal audits - Developement and maintaining internal regulatory documentation database - Negotiation with the competent authorities - Regulatory training of new employees Show less

Education

  • České vysoké učení technické v Praze, Fakulta elektrotechnická
    Inženýr (Ing.), Biomedicínské inženýrství
    2011 - 2013
  • České vysoké učení technické v Praze, Fakulta biomedicínského inženýrství
    Bakalář (Bc.), Biomedicínská a klinická technika
    2008 - 2011

Community

You need to have a working account to view this content. Click here to join now