Rebecca Stepan

Rebecca Stepan is an Instructor in the Regulatory Science & Medical Device Development program at the University of St. Thomas School of Engineering, where she teaches 'Med Device Quality Systems' (ETLS 722). She concurrently serves as Director for Quality Systems & Compliance within Medtronic's Cardiovascular Portfolio Business, leading global regulatory compliance activities including audit, safety, and quality systems oversight. With over 14 years of healthcare and medical technology experience, she previously held leadership roles at University of Minnesota Health.

Education:

• Juris Doctor (JD) in Health Law & Compliance, Mitchell Hamline School of Law
• Master of Public Health (MPH) in Epidemiology, University of Minnesota-Twin Cities
• Bachelor of Arts (BA) in Biology, University of St. Thomas

Research and Professional Focus: Her expertise centers on medical device regulatory frameworks, FDA compliance systems, international quality standards (ISO 13485), and healthcare data privacy. Current work emphasizes risk management strategies, regulatory submission processes, and corrective action protocols within cardiovascular technology.

Professional Credentials:

• Lean Six Sigma Black Belt (Villanova University)
• Certificates in Health Law, Compliance, and Privacy Law (Mitchell Hamline School of Law)
• Certification in Healthcare Compliance (CHC, HCCA)
• Professional of Healthcare Quality (CPHQ, NAHQ)

Professional Engagement: Active member of the Regulatory Affairs Professional Society (RAPS) and former Adjunct Faculty at University of Minnesota School of Public Health.