Introduction

Rebecca Stepan is the Global Director for Quality, Audit & Regulatory Compliance at Philips. She leads regulatory compliance activities for the business she supports with responsibilities spanning audit, safety, compliance, and quality systems. Rebecca's former tenures include 10 years at Medtronic and over 14 years at the University of Minnesota Health where she held the roles of Director of Quality, Regulatory & Research Practice for the Transplant Service Line and Director of Clinical Quality of the Cardiovascular Service Line. During this time she was an Adjunct Faculty at the University of Minnesota's School of Public Health.

Rebecca is a member of the Regulatory Affairs Professional Society (RAPS) and AdvaMed. She has her Lean Six Sigma Black Belt (LSSBB) from Villanova University, is an Exemplar Certified Lead Auditor, and holds a Certification in Healthcare Compliance (CHC).

Courses taught at St. Thomas:

  • ETLS 722 Medical Device Quality Systems
  • ETLS 724 Medical Device Clinical Studies
  • ETLS 734 Clinical Evidence & Reimbursement
  • ETLS 880 Regulatory Submissions Capstone

Link

Academic Areas and Departments

Regulatory Science & Medical Device Development

College of Engineering

Education

Health Law & Compliance
JD, Mitchell Hamline School of Law
Epidemiology
MPH, University of Minnesota-Twin Cities
Biology
BA, University of St. Thomas