Medical Device Regulatory and Quality Systems Consultant

Expertise

• Over 25 years of experience in medical devices.
• Experienced in all aspects of medical device product development, including design, laboratory and clinical testing, manufacturing, labeling and quality systems.
• Extensive experience in medical devices pharmaceutical and in vitro diagnostics industries.
• Extensive experience with Class II and Class III implantable medical devices for cardiovascular grafts, surgical mesh, heart valves, periodontal implants, sutures, ligaments and other devices.
• Direct interaction with FDA regarding 5.10(k), PMA submissions and 483 and Warning Letters responses.
• CFR 820 QSR/cGMP, ISO 13485 compliance.
• Process validation: Design controls.
• Analysis of clinical and laboratory testing.
• Failure modes and effects analysis; Regulatory and compliance gap analysis; Complaint files, failure investigation.
• Batch record review.
• OOS analysis, Root Cause analysis.
• Corrective Action / Preventive Action (CAPA) quality management system.
• SOP development.
• Device history record.
• Device master files.

Experience

Undisclosed University, Biological Sciences Advisory Panel, 2004 - Present

• Co-chair and Advisor to university on basic and applied ecological research.

Independent Consultant, 1998 - Present

• Senior Consultant.
• Regulatory and Quality Systems consulting.

ATA Inc, Flagstaff, AZ, Vice President, 1996 - 1997

• ATA designed and manufactured aerodynamic devices for tractor trailers.
• General business management, managed product development and prototype production.
• Wrote pro forma, business plans, and funding proposals.

W.L. Gore and Associates, Flagstaff, AZ, Associate, 1983 - 1995

• Class II and Class III implantable medical devices.
• Lead product development teams through all aspects of medical device development, from initial concepts though early stages of marketing, including market analysis, design, laboratory and clinical testing, manufacturing, regulatory and quality control.
• Internal Review Board responsibilities included release of new products, review of all Quality System and manufacturing changes, OOS products, labeling, and review of all regulatory submissions.
• Products included cardiovascular grafts, surgical mesh, combination products, heart valves, periodontal implants, sutures, ligaments and other devices.

Honors & Publications

Academic and Professional Affiliations

• American Association for the Advancement of Science

Patents

• 4 U.S. Patents

Education

• B.S. Biology, Chemistry; Northern Arizona University, Flagstaff, AZ