Speaker profile
Isabelle Lang-Zwosta
Before Dr Isabelle Lang-Zwosta joined knoell in 2007, she studied Medicine at the University of Heidelberg, gaining her doctoral degree in occupational medicine. She then changed perspective and is now using her extensive expertise to help manufacturers to bring safe and effective medical device to their desired markets.
Isabelle is currently a Global Regulatory Affairs and Business Development Manager at our knoell Medical Device office near Nashville (TN), USA.
Whilst working in the field of Clinical Safety and Global Regulatory Affairs of Medical Devices and Combination Products Isabelle has actively participated in the compilation of registration dossiers and their submission to the relevant authorities at both, a European (notified bodies), US-American (FDA) and global level.
Strategic technical planning, interaction with authorities in terms of negotiating submission strategies as well as guiding clients through the ever changing landscape of global regulatory requirements are her passion.
Aligning a client’s vision with new requirements, setting up clinical and regulatory strategies and thus bringing great and safe devices on the markets is one of the main goals to be reached.