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CCP 12-04-2000
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CCP 12-04-2000
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<br />e <br /> <br />04/95 to 04/98 - Angeion Corporation, Minneapolis, MN <br /> <br />Vice President Regulatory and Clinical Affairs <br /> <br />I developed, implemented and directed US and internationai regulatory and clinical activities <br />associated with supporting the introduction, market acceptance, quality assurance and <br />reimbursement of an implantabie cardioverter defibriliator system. Responsibilities included <br />providing strategic direction for regulatory, clinical, compliance requirements and guidance in <br />evaluation of new, existing and/or acquired products. Established compliance, vigilance, medicai <br />device reporting systems. Obtained CE Mark, ISO 9001 registration and FDA PMA approval for <br />the impiantable cardioverter defibrillator system. Responsibie for staff of 35 and budget of 5.5 <br />million. <br /> <br />11/93 to 04/95 - Empi, Inc., SI. Paul, MN <br /> <br />Director Regulatory, Clinical and Quality Assurance/Compliance <br /> <br />i directed U.S. and international activities associated with the support, introduction, regulatory <br />approval, quality assurance and reimbursement of Class I, II, Iii rehabilitative and urological <br />products. I developed and managed a staff of 17 and was responsible for budget of 2.5 million. <br /> <br />09/79 to 10/93 - Medtronic, Inc., Minneapolis, MN <br />Regulatory Affairs Manager (1986 to 1993) <br /> <br />I managed regulatory affairs for the tachyarrhythmia product line, implantable cardiac leads, <br />associated programmers, related accessories, projects, and staff. Obtained PMA approval of 2 <br />implantable cardioverter defibrillator systems, as well as PMA supplements and 510(k)s for <br />multiple cardiac leads and related accessories. Responsible for staff of 5. <br /> <br />e <br /> <br />Study Director Preclinical Research (1980 to 1986) <br /> <br />Developed Good Laboratory Practices (GLP) compliant protocols and prepared reports for <br />preclinical animal research of implantable medical devices, external instruments and related <br />accessories. <br /> <br />Battery R & D (1979 to 1980) <br /> <br />Pre- 1979 _ Warner Lambert, In-Vitro Diagnostics, Morris Plains, NJ <br /> <br />EDUCATION: <br /> <br />BGA 1982 University of MN, Minneapolis, MN <br />MBA 1991 University of Saint Thomas, SI. Paul, MN <br /> <br />e <br /> <br />2 <br /> <br />-------~~-_._---.~ -_._-~-_.- <br /> <br />-~--"-'--- ----------- <br /> <br />-.------------..--- <br />
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