Rosaleen Burke
About Rosaleen Burke
Rosaleen Burke is the Senior Vice President Global Quality and Regulatory at Boston Scientific Corporation, with extensive expertise in quality operations and regulatory processes within the medical device industry.
Current Role at Boston Scientific Corporation
Rosaleen Burke is currently serving as the Senior Vice President of Global Quality and Regulatory at Boston Scientific Corporation. In this role since 2017, she oversees the quality and regulatory processes across the company's global business. Her responsibilities ensure compliance and maintain the high standards of quality required in the medical device industry. Boston Scientific's headquarters for global operations are located in Marlborough, Boston, MA.
Previous Positions at Boston Scientific Corporation
Rosaleen Burke has held numerous roles at Boston Scientific Corporation over the years. She has been the MSVP Quality for Endoscopy and Urology and Pelvic Health since 2015. Prior to that, she served as the VP of Global Distribution and International Quality from 2010. From 2009 to 2010, she held the position of Corporate Quality Director (Lean Business Process), and from 2005 to 2009, she was the Quality Systems Director for the CV Division. Earlier roles include Quality Site Director from 2003 to 2005 in Galway.
Educational Background
Rosaleen Burke has a strong educational foundation. She earned her Master of Business Administration (M.B.A.) from Oxford Brookes University between 2004 and 2006, focusing on Business Administration and Management. Before that, she completed her Master’s Degree in Biotechnology at the National University of Ireland, Galway, from 1993 to 1995. Additionally, she gained a Bachelor of Science (B.Sc.) in Microbiology and Biochemistry from the same institution.
Expertise in Quality and Regulatory Affairs
Rosaleen Burke has extensive expertise in various quality and regulatory domains within the medical device industry. She is proficient in DMAIC, Verification and Validation (V&V), and Change Control. Her skills in Quality Operations and Quality Systems have been pivotal in her leadership at Boston Scientific, assuring the company maintains regulatory compliance and high product quality standards.