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<br />CURRICULUM VITAE <br /> <br />. <br /> <br />Jennifer M. Marrone <br /> <br />3156 Shorewood Drive <br />St. Paul, Minnesota 55112 <br />Phone: 651-636-4184 <br />Fax: 651-635-9669 <br /> <br />PROFESSIONAL EXPERIENCE: <br /> <br />I have 20+ years of experience in the medical device industry, including specific expertise in <br />managing regulatory and clinical affairs and quality system/compliance activities for small, <br />medium and large manufacturers of medical devices. My experiences include obtaining <br />regulatory approvals for ciinical studies and market release of medical products in accordance <br />with international and U.S. FDA regulatory requirements and international requirements, e.g., the <br />Medical Device and Active Implantable Medical Device Directives. I have successfully managed <br />regulatory, clinicai and quality system/compliance departments for medical device companies, and <br />have demonstrated leadership in communicating and educating the regulatory, clinical and quality <br />requirements specific to the medical device industry. <br /> <br />I have a Masters of Business Administration. Over the years I have participated in various task <br />forces for HIMA and Medical Aiiey and continue to present regulatory, clinical and quality and <br />compliance topics at numerous Industry and trade association meetings. <br /> <br />. <br /> <br />04/99 to present - Regulatory & Clinical Research Institute (RCRI), Inc., Minneapolis, MN <br /> <br />Founder & Principal <br /> <br />As a consultant to medical device manufacturers, I provide regulatory assistance and service <br />related to obtaining market clearances for medical device products, in the United States and <br />internationally. This includes: assisting in strategic planning, submission preparation/writing, <br />negotiating with regulatory and health authorities, protocol and report writing, project and staff <br />management, creating technical files/dossiers, auditing to quality systems compliance/ISO <br />standards, problem analysis and corrective/preventive action planning. <br /> <br />Administrative duties within RCRI include business strategic planning and financial management. <br /> <br />10/98 to 03/99 - Regulatory Strategies, Inc., Minneapolis, MN <br /> <br />Principal <br /> <br />Consultant to medical device manufacturers, providing reguiatory assistance regarding strategies, <br />governmental submissions, clinical study protocols, reports, technical files, audits, compliance, <br />education, training and related needs in order to facilitate market clearances for their medical <br />device products worldwide. <br /> <br />. <br /> <br />1 <br />