Jakub Dubowik

A graduate of the Poznań University of Economics and Business (specializing in Quality Management). He is an experienced Clinical Project Manager with a unique dual background, combining years of practice in strategic regulatory consulting with comprehensive operational management of clinical trials for medical devices (MD) and performance studies for in vitro diagnostic devices (IVD). He is responsible for the end-to-end coordination and oversight of global clinical projects, with a particular focus on devices in the fields of cardiology and aesthetic medicine. He possesses extensive experience collaborating with international Sponsors and CROs, particularly within the rapidly growing East Asian market (including South Korea). His expertise spans the early planning stages - from feasibility assessments and study design support to the rigorous management of contracts, budgets, payments, and resource allocation. He ensures the highest quality of medical data collection and reporting, maintaining full compliance with Good Clinical Practice (GCP) standards, Standard Operating Procedures (SOPs), and Quality Management Systems (QMS). Leveraging his consulting background, he successfully navigates the complex legal and regulatory landscape governing medical devices. He specializes in projects involving Software as a Medical Device (SaMD), particularly advanced solutions for gynecology, as well as IVD products and Class I medical devices. His in-depth knowledge of regulatory requirements enables the creation of tailored strategies and tender documentation that directly support the long-term business goals of clients and sponsors.