Vesna Kostanjevecki

Dynamic, enthusiastic senior R&D leader with 20+ years experience delivering innovative medical devices and IVDs to regulated healthcare markets. Proven success in aligning cutting-edge technology, market insights, and customer needs. Strong track record of developing clinically validated assay systems and securing global regulatory approvals. Skilled at building agile, diverse teams and effectively collaborating with stakeholders and people at all levels in a dynamic environment. Expertise in launching high-quality products within tight timelines while balancing short-term profitability and long-term strategic objectives.

Adequate knowledge of Word, Excel, PowerPoint, Outlook

• Development, clinical trials, and registration of an ultrafast, PCR-based Covid 19 molecular test.
• Development, registration, and improvement of IVD assays in the field of neurodegeneration, cardiac disease, and infectious diseases.
• Skills covering multiple domains of assay development lead by design control principles, and in compliance with ISO, FDA, and PMDA regulations.
• In Vitro Diagnostic System Development (specialty molecular diagnostic assays, immunoassays, and IVD instrumentation).
• High-end analytical platforms tailored to biomedical research and clinical diagnostics.
• Clinical value generation and assay performance validation through a global KOL network.
• Creation of design history files in Europe and transfer to Japanese and US entities to enable local manufacturing.
• Quality Compliance and Manufacturing Processes.
• Strong knowledge of IVD Directive and transition to IVD Regulation.
• Strong professional network in the areas of molecular diagnostics, protein engineering, and analytics in industry and academia.

• Individual Leadership Coaching by Scorta
• Leadership Program by De Witte & Morel
• Change Management by Hudson
• Performance Management by Hay
• Data Management and Lean for Managers Training by Amelior
• Frequent attendance at MedTech Europe Regulatory Affairs Committee
• IVDR training by QARAT
• FDA Readiness by Center for Professional Advancement
• Recurrent trainings in IVD Regulations, Quality Systems Standards and Validation (Management Forum)
• Scientific background in areas of Biomarker research and development, Alzheimer Disease, Infectious and liver diseases
• Background in analytical and molecular technologies
• Continuous follow-up on recent developments and advances through relevant annual conferences (TRICON San Francisco, Assay Development Conference Boston, American Association of Clinical Chemistry, Alzheimer Association International Conference, European Cystic Fibrosis Conference…)

• Literature
• Gardening
• Music
• Ceramics