Regulatory Affairs and Services (M.S.)

Faculty

Cathy Krier

Program director
MBA, Capella University
B.S., Milwaukee School of Engineering

(320) 308-6000 | Twin Cities Graduate Center
ckrier@stcloudstate.edu
Cathy Krier has 20 years of medical device industry experience in a variety of roles such as clinical, quality, regulatory and business management. For 10 years, she also served as a leadership coach for a non-profit organization and delivered peer-to-peer education programs for medical device and engineering communities.

Athula Abeyratne

Adjunct faculty
Ph.D.

Athula Abeyratne has been working for Medtronic more than 20 years as a statistician. Abeyratne has worked with clinicians, scientists and engineers in a variety of applications of statistics, including pivotal clinical studies and device manufacturing quality systems.

Michael Armstrong

Smiths Medical

Prithul Bom

Adjunct faculty
MBA, RAC, ASQ-CSQE

Prithul Bom is a senior director in scientific strategy, medical device and diagnostics development at Chiltern International. She started in the healthcare industry at an application developer in 1998. She has spent nine years in medical device and four years performing third-party reviews of 510(k) under the FDA Accredited Person Program and regulatory, clinical, quality and scientific strategy. Bom is well versed in regulatory considerations surrounding total product life cycle of a medical device or diagnostic. She is a guest lecturer in regulatory sciences at The George Washington University, School of Medicine & Health Sciences, Washington D.C.

James M. Broge

Adjunct faculty
Ph.D.
Director of Quality, Minnetonka Boston Scientific

James Broge has led quality teams in the Medical Food and Medical Device industries for more than 20 years. Currently, he leads the complaint investigations, trending and analysis function as part of the Global Post Market Quality Assurance organization within Boston Scientific. His experiences include management of laboratories, quality systems, audits and quality operations. 

Barbara Chiponis

Adjunct faculty
JD, MBA, RAC

Barbara Chiponis is a senior principal regulatory affairs specialist at Medtronic. She has spent 19 years in the medical device industry working with regulatory agencies around the world to obtain product approvals of pacemakers, implantable defibrillators and RF ablation generators and catheter in vitro diagnostics and drug delivery systems. She previously held leadership positions in quality systems, hosting several successful FDA inspections and notified body audits.

Mark DuVal

Adjunct faculty
P.A.

Mark DuVal is president of DuVal and Associates. He has more than 15 years of experience as general counsel to 3M Pharmaceuticals, 3M Drug Delivery Systems, and later FDA and compliance counsel at Medtronic, before starting his private practice specializing in FDA law and representing medical device, pharmaceutical and nutritional supplement companies.

Amy Fowler

Adjunct faculty

Steve Gompertz

Adjunct faculty

Brent Hathcock

Adjunct faculty

Chad Hedlund

Adjunct faculty
M.A. Clinical Exercise Physiology

Chad Hedlund has five years in the medical industry and more than 11 years of experience working in the medical device industry. He currently leads the Patient and Technical Services function as part of the Customer Support and Vigilance organization within Medtronic Neuromodulation business. His experiences within the medical device industry include management of global complaint handling and regulatory reporting, complaint investigations, compliance, patient services and technical services.

Mary Beth Henderson

Adjunct faculty
Ph.D.

Mary Beth Henderson is the principal adviser for the Regulatory & Clinical Research Institute (RCRI). She has 25 years of experience in the medical device and biotechnology industries in the area of regulatory affairs, quality systems, combination products, technology transfer and intellectual property management.

Mark Kramer

Adjunct faculty
M.S. Biomedical Engineering

Mark Kramer is president of Regulatory Strategies, Inc. He is the former director of FDA's Office of Combination Products, with 17 years at FDA and nine years in the medical device industry. He currently leads regulatory consulting practices specializing in medical device and combination products.

Marie Kuker

Adjunct faculty
Rph, FRAPS, RAC

Marie Kuker is president of Kuker Regulatory Consulting, LLC. She had more than 25 years regulatory experience in the pharmaceutical industry before starting a regulatory consulting firm specializing in biomedical regulatory affairs.

Kathleen Lundberg

Adjunct faculty
MS Biostatistics/Computer Science

Kathleen Lundberg is a current consultant and retired as Chief Compliance Officer (Global Compliance) of Boston Scientific.  Ms. Lundberg has over 25 years of experience and leadership in the medical technology field. Prior to Boston Scientific she was Compliance Officer and Vice President of Regulatory, Clinical and quality of Corventis and Chief Compliance Officer of Guidant Corporation.

Mona Magnuson

Adjunct faculty

Mona Magnuson has worked 26 years in the medical device industry including 10 years as a medical technologist; 16 years in regulatory and quality assessments training with TUV SÜD, SGS, BSI, NSAI, primarily international, European Union and Canada; auditing and systems development for QS, and compliance to ISO 13485, FDA QSR, CMD. She is owner of QRCS, a consultant and notified body auditor for NSAI. 

Angela Mallery

Adjunct faculty
EdD

Angela Mallery is a project manager for NAMSA. She has more than 20 years of experience working in device regulatory affairs in small, medium and large sized companies. She is currently a project manager and regulatory consultant on worldwide device regulatory registrations.

Melissa Martinson

Adjunct faculty
PhD

Melissa Martinson is president of Technomics Research, LLC. She has more than 20 years of experience working in and consulting to the medical device and pharmaceutical industries on statistics for clinical trial design, and analysis on health economics for product value definition, coverage and reimbursement.

Daniel Moelands

Adjunct faculty

Rica Morris

Adjunct faculty
MBA

Rica Morris is the president of Japan Regulatory Solutions LLC. She has extensive experience working in both United States and Japanese medical device industries. She consults on regulatory submissions
and quality system applications for entering Japanese market.

David Mueller

Adjunct faculty
M.S. Toxicology

David Mueller is a principal regulatory affairs specialist for American Medical Systems. He is an industry representative to the FDA Neurological Devices Panel. Mueller has more than 25 years of medical device industry experience including 3M, Medtronic, St. Jude Medical and private consulting in regulatory affairs, clinical, quality and toxicology/biocompatibility. He has extensive experience in Class I, II and III neurological and cardiovascular devices as well as international biocompatibility, clinical standards and bovine spongiform encephalitis (BSE).

Sue Norenberg

Adjunct faculty
BA, MBA

Sue Norenberg is the senior manager and clinical quality at Medtronic. She has more than 25 years in the medical device industry, including R&D, clinical trial management, pre-clinical, IDE and post market domestic, international studies and regulatory compliance.

Brian Novak

Adjunct faculty

Brian Novak is vice president of Regulatory Affairs, Interventional Cardiology at Boston Scientific. He has more than 18 years of experience in the medical device industry working with regulatory agencies around the world to obtain approval of products such as pacemakers, implantable defibrillators and stents. He has previously held various positions in engineering, design assurance and quality systems.

Lisa Olson

RCRI

Susan Petersen-Stejskal

Adjunct faculty
RN, BSN

Susan Petersen-Stejskal is vice president of Clinical Research for BioControl-Medical. She has more than 25 years as research nurse clinician and manager. She has had three original panel track FDA PMA submissions with more than 20 PMA-S requiring prospective clinical data.

Amra Racic

Adjunct faculty

Amra Racic works in Global Regulatory Affairs at Medtronic’s Minneapolis office. She has over 11 years of regulatory experience in the medical device industry supporting numerous high and low risk devices. She is currently primarily focused on internal regulatory policies and worldwide advocacy effort for the corporation.

Scott Sardeson

Adjunct faculty

Scott Sardeson is an international regulatory manager for 3M. He has more than 12 years of experience in the device industry. He currently manages registrations and assures compliance with 3M subsidiaries around the world.

Dawn Stenstrom

Adjunct faculty
MT(ASCP), MBA, RAC

Dawn Stenstrom works in Global Regulatory Affairs with Boston Scientific. She has 15 years of regulatory experience in the medical device industry supporting cardiovascular, neuromodulation, spinal biologics, medical device software and in vitro diagnostics products. She is currently providing strategic regulatory leadership on internal global regulatory policy and industry advocacy efforts.

Charles Swanson

Retired Program Director

Charles Swason was the first director of the regulatory affairs and services graduate program at St. Cloud State University,  He has more than 30 years of regulatory experience, including 29 years at Medtronic. He held several leadership positions at Medtronic, including chief quality and regulatory officer, and actively worked through AdvaMed to influence FDA policy for
medical devices.

Sam VanNorman

Adjunct faculty
MBA

Sam VanNorman is director of Business Intelligence and Clinical Analytics at Park Nicollet Health Services. He manages a performance analytics team at a large urban safety-net hospital. He has experience with healthcare economics, decision analysis, health insurance and finance with Fortune 500 companies, nonprofits and startups.