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Nadiia Misiats
Medical Writer
Medical Writer skilled in literature review, clinical data interpretation, and
preparation of regulatory documentation for medical devices and IVDs in
compliance with EU regulatory standards.

Open to transition into roles as a Clinical Evaluation Specialist, Medical
Editor, Scientific Researcher, Medical Communications Specialist.

Work Experience
Contact May 2022 - Nov 2025
Medical Writer in Regulatory Affairs
Tel: [открыть контакты](см. выше в блоке «контактная информация»)
thinqbetter GmbH
Email: [открыть контакты](см. выше в блоке «контактная информация») Hamburg, Germany
LinkedIn: [открыть контакты](см. выше в блоке «контактная информация») Creation of Clinical Evaluation Plans and Reports (CEP/CER) in accordance
m-medical-writer with EU MDR 2017/745, MDCG guidances, MEDDEV 2.7/1 Rev. 4, and internal
SOPs for class I–IIb medical devices.
Currently based in: Burgas, Bulgaria Creation of Biological Evaluation Plans and Reports (BEP/BER) in accordance
with ISO 10993-1, ISO 14971 and internal SOPs, including selection of
applicable endpoints, material characterisation, and toxicological risk
assessment for class I-IIb medical devices
Education Creation of Performance Evaluation Plans and Reports (PEP/PER) in
accordance with IVDR 2017/746 and internal SOPs for class A-B IVDs
Sep 2014 - Jun 2018 Execution of systematic literature searches in PubMed, Cochrane, and
National University of “Kyiv- Embase, including screening, critical appraisal, and data extraction to support
clinical, biological, and performance evaluations
Mohyla Academy”
Assisting in gap analysis of technical documentation to support alignment with
Bachelor in Biology EU MDR and IVDR requirements
Hryhoriya Skovorody St, 2, Kyiv, Providing consultancy support for FDA and MHRA (UK Responsible Person)
Ukraine, 04655 submissions, including preparation and adaptation of regulatory
documentation in line with submission requirements.
Sep 2020 - Dec 2021 Improving internal templates to ensure consistency and compliance with
internal procedures and regulatory expectations
Taras Shevchenko National
University of Kyiv
Master of Immunology Jul 2020 - Jan 2022
Volodymyrska St, 60, Kyiv, Ukraine, Medical Registrar
01033 Medical Laboratory “DILA”
Kyiv, Ukraine
Mar 2023 Registration and documentation of human biological samples, ensuring
TECH Global University accurate patient and specimen identification
Ensuring correct labelling, traceability, and storage of samples according to
Postgraduate Certificate in
internal SOPs
Immunology in the Field of Clinical Coordination with laboratory technologists and clinicians to support timely
Analysis test processing and reporting
Online education Assisting in routine quality control and equipment maintenance procedures
Compliance with national requirements for laboratory safety, biosecurity,
and confidentiality

Languages Skills
Ukrainian - Native
Creativity Multitasking
English - Fluent
Organized Critical thinking
Spanish - Upper-intermediate
Teamwork Attention to detail
Czech - Upper-intermediate Project management Continuous learning
Deutsch - Elementary