Germany
I lead the US subsidiary of a European neurovascular MedTech company with full P&L responsibility and end-to-end ownership across strategy, regulatory, clinical and organizational development. My background combines management with deep experience in regulatory strategy and market access in high-tech medical device environments. I work closely with shareholders and boards on strategic direction and risk. Trained in both law and neuroscience, I approach leadership with a dual lens: regulatory rigor and scientific reasoning.
Built and led the US subsidiary of a European neurovascular medical device company from inception to first commercial patient. Full P&L responsibility and end-to-end ownership of US strategy across regulatory, clinical, commercial and organizational build-up. – Executing US market access and FDA pathways for Class III neurovascular implants – Established US operations, legal entity, governance and cross-border structures – Direct interface to shareholders and board on strategy, risk and performance – Led OEM and strategic partner negotiations in the US – Built and scaled a bi-national leadership team across regulatory, clinical and market access
Overall leadership for all US-related business activities of a European neurovascular medical device company, covering market access, regulatory strategy, clinical positioning and commercial strategy. In parallel, built a new pharmaceutical wholesale business line from the ground up to streamline supply chain, production and market availability of innovative coating technologies. – Designed and executed integrated US market entry strategies across regulatory, clinical and commercial dimensions – Established and operationalized a pharmaceutical wholesale entity from inception to full regulatory approval and live operations, thereby re-engineering supply chain and production interfaces – Led negotiations with OEM partners, distributors and industry stakeholders in the US – Held responsibility for contractual frameworks and all legal matters – Acted as strategic interface between German headquarters and US subsidiary on growth priorities and risk management
Led global regulatory strategy across CE, IDE, PMA and 510(k) pathways. – Prepared and led FDA pre-submissions – Supported executive decision-making on portfolio and market prioritization – Responsible for company legal affairs in close cooperation with external counsel and all in-house medical law interpretation (MDR, MPDG, HWG, UWG)
Medical device registrations of class III neurovascular stents – Designed cross-regional approval strategies (EU–US–Asia) – Led implementation on new UDI and Labelling framework as part of company-wide MDR transition
Investigating the role of parietal cortex in visual perception using magnetic neurostimulation and magnetic resonance imaging
Design, analysis, & publication of numerous studies on higher brain networks in visual selection.
Led joint international projects on researching the role parietal cortex in attention