Karen Gutekunst

Vice President of Regulatory Affairs


Karen Gutekunst is currently Vice President of Regulatory Affairs at Illumina. Karen holds a Ph. D. from the Georgia Institute of Technology and has over 25 years in the diagnostic industry. Karen leads a team of regulatory specialists who are responsible for taking Illumina’s cutting edge sequencing technology and instrumentation through regulatory approval processes world-wide. Karen has held a variety of roles within Illumina and within the industry over the years including leading product development, project management and organizational efficiency programs. Karen has a passion for enabling technology to be used to improve healthcare. As part of the Illumina team, she is excited to see next generation sequencing transform the way we think about complex genetic diseases, particularly cancer. Karen also believes in developing our next generation of leaders who will continue to bring innovation into the healthcare space.