Martyna Budziosz-Dębicka

Junior Regulatory Affairs and Quality Specialist at Cardiomatics
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Contact Information
us****@****om
(386) 825-5501
Location
Poznań, Wielkopolskie, Poland, PL
Languages
  • polski Native or bilingual proficiency
  • angielski Limited working proficiency

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Credentials

  • Quality Tools - narzędzia jakości
    TQMsoft
    Oct, 2019
    - Nov, 2024
  • Sztuka autoprezentacji i prowadzenia spotkań
    Progress Project
    Oct, 2019
    - Nov, 2024

Experience

    • Poland
    • Software Development
    • 1 - 100 Employee
    • Junior Regulatory Affairs and Quality Specialist
      • Dec 2022 - Present

      Main responsibilities: - defining regulatory requirements and participating in the preparation of the submissions for SaMD (Software as a Medical Device) - supporting the preparation of product technical documentation (EU, US, QMS) - monitoring, analyzing and evaluating quality indicators, audits results, feedbacks and risk management activities - preparing quality assurance policies and procedures - conducting internal audits and participating in external audits Main responsibilities: - defining regulatory requirements and participating in the preparation of the submissions for SaMD (Software as a Medical Device) - supporting the preparation of product technical documentation (EU, US, QMS) - monitoring, analyzing and evaluating quality indicators, audits results, feedbacks and risk management activities - preparing quality assurance policies and procedures - conducting internal audits and participating in external audits

    • Denmark
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Vigilance Specialist
      • Feb 2021 - Dec 2022

    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Vigilance Specialist/ Quality and Safety Specialist for Medical Devices
      • Nov 2018 - Jan 2021

    • Quality Assurance Specialist
      • Dec 2017 - Oct 2018

    • United States
    • Financial Services
    • 700 & Above Employee
    • US TA Intern
      • Mar 2016 - Mar 2017

    • Poland
    • Non-profit Organization Management
    • 1 - 100 Employee
    • Project Team Member
      • Feb 2015 - Feb 2016

Education

  • Uniwersytet Ekonomiczny w Poznaniu
    Master's degree, Management and Production Engineering
    2016 - 2017
  • Uniwersytet Ekonomiczny w Poznaniu
    Bachelor of Science - BS, Faculty of Commodity Science
    2012 - 2016

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