Aleksandra Jakacka

Regulatory Affairs Specialist at URTESTE
  • Claim this Profile
Contact Information
us****@****om
(386) 825-5501
Location
Sopot, Pomorskie, Poland, PL

Topline Score

Topline score feature will be out soon.

Bio

Generated by
Topline AI

5.0

/5.0
/ Based on 2 ratings
  • (2)
  • (0)
  • (0)
  • (0)
  • (0)

Filter reviews by:

Małgorzata Wieczorek

Aleksandra is someone who skillfully combines her experience, extensive knowledge, and diverse interests in her work. She approaches each task with careful attention, demonstrating meticulousness and a keen eye for detail. She brings a positive energy to the team and handles confrontations with confidence while maintaining strong and positive relationships with her colleagues. Working with Aleksandra has been an incredible and enjoyable experience.

Joanna Markowska

What sets Aleksandra apart is her innate curiosity and eagerness to learn. She consistently stays up-to-date with industry trends and advancements, always seeking to expand her skillset. Aleksandra brings wealth of knowledge to every project, ensuring a comprehensive understanding and delivering exceptional results. During our time working together, I have been consistently impressed by her depth of knowledge and unwavering commitment to her work. It has been a privilege to work alongside her, and I am confident she will continue to excel in all her future endeavors.

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

Credentials

  • GCP, Good Clinical Practice - Dobra Praktyka Kliniczna
    POLCRO, Clinical Research Organization
    Mar, 2021
    - Nov, 2024

Experience

    • Poland
    • Biotechnology Research
    • 1 - 100 Employee
    • Regulatory Affairs Specialist
      • Jul 2023 - Present

    • Poland
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs Specialist
      • Jun 2022 - Jun 2023

      • Performing scientific reviews based on: PubMed, Cochrane, Clinicaltrials, • Designing and preparing clinical study protocols for medical devices, • Monitoring of medical device clinical studies, • ISO 14155 • Creation of technical documentation for medical devices in compliance with MDR requirements, • Supervision and updating of documentation applicable under MDD, • Foreign registration of medical devices, • Market analysis, new legislation in the context of medical devices, • Communication and consultation with authorities, • Co-create and update artwork. Show less

  • CSDRTG
    • Gdańsk/Gdynia
    • Electroradiologist
      • Jan 2021 - Jun 2022

      Performing examination: CT-scan X-ray Performing examination: CT-scan X-ray

    • Sweden
    • Hospitals and Health Care
    • 700 & Above Employee
    • Electroradiologist
      • Jun 2019 - Jan 2021

      Performing examination: -X-ray, -Spirometry, -Filed of View, -Audiometry. Performing examination: -X-ray, -Spirometry, -Filed of View, -Audiometry.

  • Wojewódzkie Centrum Onkologii
    • Gdańsk, woj. pomorskie, Polska
    • Electroradiologist
      • Jan 2018 - Dec 2019

      Performing tests: -CT scan -Mammography -X-ray Performing tests: -CT scan -Mammography -X-ray

  • Pomorskie Centrum Stomatologii
    • Gdańsk, Woj. Pomorskie, Polska
    • Dental Asisstant - manager
      • Jul 2014 - Dec 2017

  • Gdański Uniwersytet Medyczny
    • Gdańsk, woj. pomorskie, Polska
    • Praktyki Wydział Medycyny Nuklearnej
      • Jun 2016 - Jul 2016

    • Hospitals and Health Care
    • 1 - 100 Employee
    • Praktyki Radioterapia
      • Feb 2016 - Feb 2016

  • Szpital Św. Wincentego a Paulo. Gdynia
    • Gdynia, woj. pomorskie, Polska
    • Praktyki RTG
      • Jun 2015 - Jul 2015

Education

  • Warszawski Uniwersytet Medyczny - WUM
    2019 - 2020
  • Gdański Uniwersytet Medyczny (Medical University of Gdańsk)
    Licencjat (Lic.)
    2014 - 2017

Community

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