Jelena Kresoja has joined Qserve Group as a medical writer for PMCF, where she is part of the Qserve CRO team and is based in the Netherlands.
Jelena holds a BSc and MSc degree in Biomedical Engineering. Her background lies in Medical Device Design, where she has a specialization from the University of Groningen. While working as a medical device design engineer she came in contact with the Medical Device Regulations on several occasions and understood its importance for all medical devices.
She also worked in a start-up company that was developing a device for continuous glucose monitoring with a focus on biosensors, both as a lab technician and a data analyst.
There’s a personal profile
available on this website where Jelena explains more about her experience and her core competencies.About Qserve Group
Qserve’s mission is to support all medical device and in-vitro diagnostics manufacturers with a practical approach, translating existing regulations to understandable requirements. We serve to guide manufacturers in gaining and maintaining compliance as well as conducting clinical studies as a CRO to ensure safe and quality devices in the most streamlined way possible. Qserve’s global team combines its regulatory and clinical knowledge and experience in the medical device industry, sharing more than 900 years’ worth of combined expertise in the medical field. Having teams in the EU, USA, and China provides a global footprint for global regulatory, clinical, CRO, and quality services.
Qserve is constantly looking for consultants at different career levels with experience in regulatory affairs, quality assurance, clinical affairs, or auditing to support manufacturers or distributors of medical devices and in vitro diagnostics. Check our current vacancies