Warsaw, Mazowieckie, Poland
I am an Executive leader in Life Sciences, MedTech, and Diagnostics with a strong track record in IVDR- and FDA-compliant product commercialization and international scaling. My strength lies at the intersection of technology, regulatory strategy, and market execution. I bring extensive experience in process design as well as plant and facility planning for manufacturing and office environments, consistently translating complex challenges into scalable, compliant, and results-driven solutions. As a proactive international leader, I combine strategic thinking with a hands-on approach. I build and lead high-performing engineering and operations teams, fostering accountability, motivation, and sustainable performance through a modern, collaborative leadership style. I believe operational excellence is both a business principle and a mindset — applying Lean thinking to simplify complexity and drive continuous improvement. Special Expertise: Regulatory & Market Access: Deep expertise in IVDR and FDA submissions, navigating complex global regulatory environments including the EU AI Act, European Health Data Space (EHDS), and cybersecurity requirements MedTech & Diagnostics: End-to-end product lifecycle leadership from clinical validation to commercialization in the IVD and diagnostics space Strategy & Growth: Portfolio management, go-to-market strategy, and international expansion including location and manufacturing footprint decisions Operations & Scale-Up: Proven track record in scaling manufacturing operations along supply chain, process industrialization, and supply chain optimization Quality & Compliance: Strong background in quality management systems (ISO 13485) and regulatory-compliant product development, (IATF 16949) Operational Excellence: Leading operational excellence and lean transformation to deliver superior performance, establishing resilient quality and risk governance, and unlocking enterprise value through data-driven insights and large-scale digital transformation. Engineering & Manufacturing: Expertise in medical device process development, assembly, and industrialization including microfluidics and plastic injection molding Leadership: Hands-on leadership style with strong focus on team building, performance culture, and execution excellence
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