Regulatory Strategies, Inc.

Domestic & International Medical Device Consulting
Home
About Us
Contact Us
Site Map
Experience
Client Comments
Professional Network
Experience 

 
Greg Mathison
President
 

Starting in the medical device industry at Medtronic in 1979 as a chemical engineer, Greg moved to regulatory affairs in 1984.  He has held management positions in regulatory/clinical/quality at Medtronic, Cardiac Pacemakers, Clarus Medical and Bacchus Vascular.  Greg founded Regulatory Strategies in 1993 as a full service consulting firm focusing on U.S. and international regulatory, clinical and quality.  He continues to specialize in strategic regulatory planning and finding creative solutions to regulatory issues. 


 

PROFESSIONAL EXPERIENCE

 

REGULATORY STRATEGIES, INC.                                            (1993 to present)

 

President

 

Founded in February 1993 as a medical device consulting firm specializing in creative U.S. and International regulatory / clinical strategies, quality systems and product registrations for Class I, II, and III medical devices.

 

 

BACCHUS VASCULAR, INC.                                                     (2001 – 2003)

Santa Clara, CA

 Vice President, Regulatory, Clinical Affairs and Quality Assurance

 Regulatory, clinical and quality compliance for Class II vascular devices. 

                             

CLARUS MEDICAL SYSTEMS, INC.                                           (1991 - 1993)

Golden Valley, MN 

           

Director, Clinical and Regulatory Affairs

 

Regulatory, clinical and quality compliance for Class II endoscopic devices for

orthopaedic, cardiovascular, neurological, and urological applications. 

 

CARDIAC PACEMAKERS, INC.                                                  (1987 - 1991)

St. Paul, MN 

 

Manager, Regulatory Affairs

 

Regulatory, clinical and quality compliance for Class III cardiovascular devices and Class II drug pumps

 

AMERICAN MEDICAL SYSTEMS, INC.                                       (1985 - 1987)

Minnetonka, MN 

 

Regulatory Affairs Associate

 

U.S and international regulatory / clinical submissions for Class II and III urological devices.

 

MEDTRONIC, INC.                                                                   (1979 - 1985)

Minneapolis, MN 

 

Product Regulation Manager

 

Submission of IDE, 510(k) and PMA applications for Class II and III neurological devices.

 

Chemical Engineer

 

Process development, solvent recycling, chemical and hazardous waste   handling.

 

EDUCATION

 

            Saint Olaf College                                                                          (1977-1979)

            Northfield, MN

            Major - Chemistry

 

          Hamline University                                                         (1975-1977)

            St. Paul, MN

 

 

PROFESSIONAL AFFILIATIONS AND CERTIFICATIONS

 

            Regulatory Affairs Certified (R.A.C.)   Certificate #181

            Past Member-Regulatory Affairs Professional Society (RAPS)

            Past Co-chair Medical Alley Regulatory Committee

  Past member, HIMA Product Approval and Pacemaker Task Teams

 

 

PROFESSIONAL TEACHING & SPEAKING EXPERIENCE

 

Numerous presentations on regulatory affairs, clinical studies and quality compliance to

professional conferences, medical device industry professional groups and organizations

 

 

PUBLICATIONS

 

Selecting a Notified Body for CE Marking in Europe: The Validation Consultant Vol. 3  No.6  July 1996

 

 

FOREIGN LANGUAGE

 

            German