Principal Regulatory Affairs Specialist, Medtronic
Renee Cveykus is a Principal Regulatory Affairs Specialist, at Medtronic. She joined the company in 2001 and held various positions before joining Regulatory. In 2015, Renee joined the Structural Heart Regulatory team where she manages the Tubing Pack used during cardiopulmonary bypass surgery procedures. Her main responsibilities include writing medical device global submissions plus ensuring all product changes are globally tracked on behalf of Medtronic. In addition she ensures process compliance, while driving efficiency and productivity for structural heart product in the across the regions. Before joining Regulatory, Renee held various Information Technology and Quality positions, eventually teaching and leading Lean and Six Sigma at Medtronic. Renee was one of Medtronic’s first Certified Master Black Belts and holds the record for most completed Kaizens (30+) within Medtronic. Renee is a 2013 graduate from St. Cloud State University, St. Cloud, MN with a Masters in Regulatory Affairs and Services.