Iana Slobodeaniuc
Regulations and Industrial Policy Manager IVDs at MedTech Europe- Claim this Profile
Click to upgrade to our gold package
for the full feature experience.
-
Romanian Native or bilingual proficiency
-
English Full professional proficiency
-
Italian Full professional proficiency
-
Russian Native or bilingual proficiency
-
French Full professional proficiency
Topline Score
Bio
Credentials
-
Laboratory Animal Technologist (LAT) cat B
FEDERATION OF EUROPEAN LABORATORY ANIMAL SCIENCE ASSOCIATIONSJan, 2019- Nov, 2024 -
Radiation-induced effects with particular emphasis on genetics, development, teratology, cognition as well as space-related issues
SCK CENMar, 2018- Nov, 2024 -
Certified CC (Competent Communications)
Toastmasters International -
Certified CL (Competent Leadership)
Toastmasters International
Experience
-
MedTech Europe
-
Belgium
-
Medical Equipment Manufacturing
-
1 - 100 Employee
-
Regulations and Industrial Policy Manager IVDs
-
Apr 2020 - Present
Healthcare policy, IVDR, standards. Focused on in-vitro diagnostics (IVDs) European policy. Ensuring a smooth implementation of the the new In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) across the industry. Developing standards for medical devices and in-vitro diagnostics (ISO, CEN, CENELEC). Building the knowledge of IVDR Clinical Evidence Requirements. Creating a better, stronger and safer future for medical devices in Europe. MedTech Europe is the European trade association representing the medical technology industries, including medical devices, in vitro diagnostics and digital health. Show less
-
-
-
Université catholique de Louvain
-
Belgium
-
Research Services
-
700 & Above Employee
-
Scientific Researcher (PhD Molecular Neuroscience)
-
Feb 2018 - Feb 2020
(see below the video from the research laboratory) •Literature research to deeply understand how the neural connections are assembled on molecular level, identifying the opportunities to be further investigated during my PhD •Project management to complete thesis in around the topic of brain development, molecular and genetic pathways involved in cortex formation •Awarded a two-years research grant from Belgian Fonds de la Recherche Scientifique FNRS •Performed laboratory tests, including protein interaction studies, genetic engineering, in vivo alteration of signalling pathways, cell culture, luciferase assay, histology, organotypic tissue culture assay, interpretation of video microscopy, genome-wide profiling of translating mRNAs and image analysis (includding ImageJ software) •Represented the laboratory at conferences, performed oral and written communication of scientific topics in front of experts and general public •Attended lectures and workshops on a wide range of scientific subjects, participated in round-table discussions including Biotech4Change (European meetup of young scientists at the European Parliament •Helped organize the international UCLouvain Young Researchers Days 2018: maintained communication with collaborators from EURON (European research and training network of eight universities). Assisted and welcomed the international PhD students. Created challenging mind games for participants during their free time at the symposium. Contacted the sponsors •Organised monthly meetings of PhD and PostDoc students for networking and social activities outside the University with the scope to strengthen the communication between peers and help newcomers adapt smoothly Show less
-
-
-
EY
-
United Kingdom
-
IT Services and IT Consulting
-
700 & Above Employee
-
Consultant Analyst Pharma and Medtech Market
-
Sep 2015 - Jul 2017
•I was part of a team providing scientific solutions and strategies for international pharma and MedTech companies (from global to start-ups) •I collected and systematized targeted information about the state of the market, demand, tendencies, potential target audience to advise clients on possibilities to advance the product development and commercialization in Europe and Latin America •I carefully researched the regulations and local administrative particularities to help the client efficiently and rapidly place products on the market •Draw strategies on acquisition of human capital, production capabilities, optimization and mergers •Identified and interviewed Key Opinion Leaders •Helped pharmaceutical clients, and other organizations in the broader healthcare ecosystem get products to patients faster, each project was unique and customized to clients needs Show less
-
-
-
Imunotehnomed "Medexpert"
-
Chisinau, Moldova
-
Clinical Laboratory Manager
-
Dec 2014 - Sep 2015
•I was responsible for the in-vitro diagnostic tests: procedures, protocols planning, preparing and quality control check •RT PCR (identification of viral and bacterial infections: HIV, HCV, HBV, Borrelia etc.), Genotyping, Flow cytometry, Microscope Immunophenotyping •Supervised the team of technicians •Conducted pre-sales presentations and equipment demonstrations (the laboratory is importing and distributing MedTech and in-vitro diagnostic reagents, I was directly interacting with potential clients) Show less
-
-
-
Institute of Oncology of Moldova
-
Chisinau, Moldova
-
Research Laboratory Technician
-
Apr 2014 - Dec 2014
•Performed molecular experiments: Immunophenotyping, PCR, ELISA, Microscope analysis •Inventory control - proactively managed laboratory stock, devices and protocols to support the smooth running of operations •Oversaw laboratory records •Contacted patients to be enrolled in the research study “Dynamics of the immune cells in patients with ovarian cancer - before, during and after cryotherapy” •Performed molecular experiments: Immunophenotyping, PCR, ELISA, Microscope analysis •Inventory control - proactively managed laboratory stock, devices and protocols to support the smooth running of operations •Oversaw laboratory records •Contacted patients to be enrolled in the research study “Dynamics of the immune cells in patients with ovarian cancer - before, during and after cryotherapy”
-
-
Education
-
2022 - 2023
Regulatory Affairs Professionals Society | RAPS
Dual Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals -
2018 - 2020
Université catholique de Louvain
Doctor of Philosophy - PhD, Neuroscience, developmental neurobiology -
University of the Academy of Sciences, Moldova
Master of Science (MSc), Molecular Biology -
Università degli Studi di Padova, Italy
Bachelor of Science (BSc), Biotechnology -
National College of Trade (Academy of Economic Studies of Moldova)
Baccalauréat, Economy
Community
