MS-RAS Instructors and Developers
Maria Brittle, Ph.D., RAC
Director, Regulatory Affairs — Lumen Biomedical, Inc.
- 25 years in the medical device industry in regulatory and clinical affairs at several companies with numerous U.S. (PMA, 510k), and international submissions.
Steve C de Baca
Vice President Quality — Boston Scientific Corporation
- Responsible for the Quality Assurance system and over 400 person organization at the Maple Grove/Plymouth, MN, and two CA facilities and for the Design Assurance functions for new product development for the Cardiovascular division.
Mark DuVal
President — DuVal and Associates, P.A.
- Over 15 years 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.
Frank Freedman, Ph.D.
Consulting Partner – Alliancz Medical Consultants
- An adjunct professor at several Twin City academic institutions, he has over 30 years of experience involving medical device clinical studies and regulatory submissions.
Fred Halverson
Retired Vice President, Corporate Regulatory Strategy — Medtronic
- 30 years at Medtronic in regulatory affairs, helping to shape Medtronic’s regulatory program and strategy with extensive experience in OUS regulatory strategy
Mary Beth Henderson, Ph.D.
Principal Advisor — RCRI
- More than 20 years in the medical device and biotechnology industries with experience in global regulatory requirements, quality systems, product and process development, tech transfer & IP management
Judith M. Hickey
President & Co-founder — Princeton Reimbursement Group
- More than 20 years experience in reimbursement and health care policy in the medical device and diagnostics industry.
Rich Jansen, Pharm. D.
President — Silver Pine Consulting
- 16 years specializing in spinal implant devices regulatory and clinical affairs and previously a hospital pharmacist/clinical researcher and IRB Chairman.
Mark Job
Owner / Reviewer — Regulatory Technologies Services, LLC
- Eight years performing third-party reviews of 510(k) under the FDA Accredited Person Program, completing more than 300 510(k) submissions
Christopher Lyle, M.S.
Principal Advisor and Director of Biostatistics & Information Systems — RCRI
- Directs data analysis and database development for RCRI, Inc. and consults on clinical trial design, analysis plan development and economic analyses.
Jennifer Marrone
Executive VP / Senior Principal Advisor & Co-founder — RCRI
- Has significant experience in regulatory submissions and working with government to obtain IDE clinical study approval as well as pre-market approval (PMA) for many types of devices.
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Carla Monacelli
Managing Partner & Co-founder — Argenta Advisors, LLC
- Nearly 20 years experience in policy, reimbursement and government affairs for the life sciences industries, including serving as the Senior Director of Healthcare Affairs for Conceptus Inc.
Sue Norenberg
Sr. Principal Research Consultant / CRO Manager — Medtronic
- More than 25 years in the medical device industry, including R&D, clinical trial mgmt., pre-clinical, IDE and post market domestic and international studies, as well as regulatory compliance.
Stephan Norsted, Ph.D., MPH
President and CEO — RCRI
- Epidemiologist who has worked in the design and analysis of clinical trials since 1980, is a frequent lecturer at national conferences and universities and is currently the president of one of the largest CROs in the US.
Susan Petersen-Stejskal
Vice President, Clinical Research — Cardiac Concepts, Inc.
- More than 25 years as research nurse clinician and manager and has three original panel track FDA PMA submissions with more than 20 PMA-S requiring prospective clinical data.
Scott Sardeson
International Regulatory Manager — 3M
- With more than 12 years experience in the device industry he currently manages registrations and assures compliance with 3M subsidiaries around the world.
Monica Schultz
Director of Reimbursement — RCRI
- More than 15 years in the medical device industry in reimbursement and post-approval studies and has served as research analyst for Blue Cross Blue Shield of Minnesota.
Deborah Shatin, Ph.D.
Principal — Shatin Associates, LLC
- More than 25 years in the health care industry including conducting domestic and international clinical trials at Medtronic, and at UnitedHealth Group directing pharmacoepidemiology studies, therapy safety surveillance for FDA, and health services research.
Charmaine Sutton
President and Principal Consultant — The Tamarack Group
- Expert in gaining market authorization of Class II and III devices and in development and implementation of ISO 13485 and FDA QSR quality systems
David A. Teicher, Esq.
Associate Attorney — DuVal and Associates, P.A.
- Nearly 30 years in regulatory affairs starting as a biomedical engineer investigator with the FDA for 11 years, then device companies, and for the last 3 years as an attorney at DuVal.
Barb Veath
Senior Reimbursement Manager — Medtronic, CRDM
- Over 20 years in the health care industry currently focusing on Clinical Trial Reimbursement Compliance and Health Policy for Medtronic’s Cardiac Rhythm Disease Management Div.
Richard R. Wilson, M.D.
- Over 30 years in developing drugs and medical devices
- Medical Director and Chief Medical Officer for pharmaceutical and medical device firms
- Co-founder of three medical device companies
Winifred Wu
Vice President, Regulatory Affairs and Vigilance — Medtronic, Neuromodulation
- More than 25 years in the device and pharmaceutical industries in regulatory, clinical, quality and program management.
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