Lobke Meels
Quality and Regulatory Affairs Manager at Xyall- Claim this Profile
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Bio
Credentials
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FDA Medical Devices
MikrocentrumMay, 2023- Sep, 2024 -
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO13485:2016)
ProPharma GroupApr, 2021- Sep, 2024
Experience
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Xyall
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Netherlands
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Medical Device
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1 - 100 Employee
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Quality and Regulatory Affairs Manager
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Sep 2022 - Present
Xyall digitizes and automates the tissue dissection workflow to help pathologists obtain more reliable molecular diagnostic test results. Responsible for the Quality Management System (ISO 13485:2016 and 21 CFR 820) and regulatory complicance (IVDR and 21 CFR 800-861) Xyall digitizes and automates the tissue dissection workflow to help pathologists obtain more reliable molecular diagnostic test results. Responsible for the Quality Management System (ISO 13485:2016 and 21 CFR 820) and regulatory complicance (IVDR and 21 CFR 800-861)
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CELTIC Medical
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Netherlands
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Medical Equipment Manufacturing
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1 - 100 Employee
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Developer for Health Economics, Quality and Regulatory Affairs
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Mar 2021 - Sep 2022
Celtic Medical aims to drastically improve the screening of colorectal cancer by introducing a liquid biopsy test based on a gene expression profile. The CELTIC test panel will be developed as an add-on to the colorectal cancer screening approach with FIT- tests to be followed by improved methods that will challenge the position of the FIT test as the current primary screening test. Celtic Medical aims to drastically improve the screening of colorectal cancer by introducing a liquid biopsy test based on a gene expression profile. The CELTIC test panel will be developed as an add-on to the colorectal cancer screening approach with FIT- tests to be followed by improved methods that will challenge the position of the FIT test as the current primary screening test.
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Bilihome B.V.
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Netherlands
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Medical Equipment Manufacturing
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1 - 100 Employee
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Clinical and Health Economics Student Worker
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Sep 2020 - May 2021
Bilihome offers uncompromised bonding with wearable blue light therapy for jaundiced newborn and parents. Bilihome is the user driven innovation that enables safe and effective phototherapy treatment at hospitals and home. Bilihome offers uncompromised bonding with wearable blue light therapy for jaundiced newborn and parents. Bilihome is the user driven innovation that enables safe and effective phototherapy treatment at hospitals and home.
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MLA Diagnostics
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Netherlands
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Medical Equipment Manufacturing
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1 - 100 Employee
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Research and Development Assistant
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Sep 2019 - Jul 2020
MLA Diagnostics BV has licensed technology from the University of Maastricht / Maastricht University Medical Center. In collaboration with these institutes MLA Dx is developing a new prognostic test for early stage melanoma evaluation. MLA Diagnostics BV has licensed technology from the University of Maastricht / Maastricht University Medical Center. In collaboration with these institutes MLA Dx is developing a new prognostic test for early stage melanoma evaluation.
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Maastricht UMC+
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Netherlands
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Hospitals and Health Care
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700 & Above Employee
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Research And Development Assistant - Department of Pathology/ Medical Oncology
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Aug 2019 - Mar 2020
Performing systematic literature search to diagnostic biomarkers in colorectal cancer.
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Bachelor Intern - Department of Pathology/ Medical Oncology
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Apr 2019 - Jul 2019
Internship at the Department of Pathology of MUMC+/ Maastricht University. During this internship I researched circulating cell free DNA and extracellular vesicles in urine as a potential biomarker for renal cell carcinoma. Grade 8.2/10
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Rode Kruis Studentendesk
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Netherlands
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Non-profit Organization Management
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1 - 100 Employee
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Board member
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Jul 2018 - Jul 2019
Together with our committee members and volunteers we arranged and developed several (new) projects for the students and the community of Maastricht. Together with our committee members and volunteers we arranged and developed several (new) projects for the students and the community of Maastricht.
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Universiteit Maastricht
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Netherlands
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Restaurants
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Internship - Department of Bioinformatics
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Feb 2019 - Mar 2019
Internship at BiGCaT (Department of Bioinformatics) of Maastricht University. Focusing on the creation of metabolic pathways with the use of several bioinformatic tools and databases (results published on wikipathways.org). Grade 8.0/10. Internship at BiGCaT (Department of Bioinformatics) of Maastricht University. Focusing on the creation of metabolic pathways with the use of several bioinformatic tools and databases (results published on wikipathways.org). Grade 8.0/10.
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Student Assistant
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Oct 2018 - Jan 2019
Measuring the quality of care and services in nursing homes from the residents and relatives' perspective through NPS Measuring the quality of care and services in nursing homes from the residents and relatives' perspective through NPS
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Education
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2020 - 2022
MCI | The Entrepreneurial School®
Master, European Master Health Economics and Management -
2020 - 2022
Universitetet i Oslo (UiO)
Master, European Master Health Economics and Management -
2020 - 2022
Erasmus Universiteit Rotterdam
Master, European Master Health Economics and Management -
2015 - 2019
Universiteit Maastricht
Bachelor, Biomedische wetenschappen (Biomedical Sciences) -
2008 - 2015
Graaf Huyn College
Voorbereidend Wetenschappelijk Onderwijs
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