Alyssa Burke

WORK HISTORY

EDUCATION

SKILLS

ABOUT ALYSSA BURKE

I am passionate about bringing positive change to healthcare, whether that is in R&D, regulatory affairs, or medical communication. By training, I am a biomedical engineer and regulatory professional but also have a diverse background in communication, quality system management, and patient advocacy. My goal is to bring awareness and understanding to complex medical conditions including gastrointestinal diseases and other autoimmune disorders. I am an effective communicator with both technical and lay language in order to interact with all interested parties. My track record demonstrates timely decision making and results oriented attitude by effectively managing priorities. I am an experienced leader in both professional and academic settings.I have project management experience in designing a catheter based medical device from clinical need through validation testing. Additionally, I use engineering techniques to develop effective verification and validation procedures that include risk management considerations. I also have experience in updating and maintaining Quality Management Systems in compliance with ISO 13485, 21 CFR 820, EU MDD and EU MDR.I completed my undergraduate work at Bucknell University in 2014 in Biomedical Engineering. During my Master\'s and Ph.D. at the University of Kansas, my research was focused on the development of novel medical devices. I am actively involved with Women in Bio, Girl Scouts USA, the Crohns and Colitis Foundation of America, and the Biomedical Engineering Society.