I have over 20 years of experience in regulatory affairs, quality assurance, and clinical affairs for medical devices, combination products, and in vitro diagnostics, with a focus on start-up environments. I have a proven track record of developing and implementing global regulatory strategies, preparing and submitting regulatory submissions and registrations, conducting and managing audits, and overseeing product development and quality systems. I have extensive knowledge and experience in the EU Medical Device Regulations and In Vitro Diagnostics Regulations (MDR and IVDR), the FDA regulations and guidance, and the international standards and requirements for medical devices. I have successfully worked with various energy modalities, implantable devices, minimally invasive surgery, companion diagnostics, and device software, including medical device apps (SaMD). I am passionate about advancing the field of medical device innovation and ensuring patient safety and compliance. As the SVP of Regulatory Affairs at NeVap, I lead the quality and regulatory functions for a medical device company that develops innovative solutions for respiratory care.