Education:
A.B. in Biology, Chemistry- minor, 1964, Catawba College, Salisbury, N.C.
M.S. in Medical Physics - Radiology, 1972, University of California, Los Angeles
Certification:
Radiological Physics by American Board of Radiology: - June 1977 Certification includes Therapeutic Radiological Physics, Diagnostic Radiological Physics and Medical Nuclear Physics.
Experience:
Quality and Regulatory Services, Inc. 1994 to present.
President.
Company provides compliance solutions to medical device manufacturers for CDRH/FDA medical device regulations including training, IDE, PMA, 510(k), audits, and 483/Warning letter recovery and assists with ISO quality systems training, implementation and audits.
Siemens Medical Systems, Oncology Care Systems, (formerly Siemens Medical Laboratories) 1989-1994.
Director, Quality Systems and Regulatory Affairs.
Advised senior management and interacted with FDA and State regulatory authorities to maintain compliance with medical device and radiation safety regulations. Produced and submitted 510 (k)'s, listings, MDR's, recalls and 483 responses. Responsible for quality engineering activities. Initiated ISO 9001 and quality improvement programs and coordinated training for all 330 employees.
Member U.S. delegation to International Electrical Commission (IEC) Technical Committee 62C, Working Group #1 Safety of Radiation Therapy Equipment 1989-1994.
Chairman, Radiation Therapy Section, Diagnostic Imaging and Therapy Systems Division, National Electrical Manufacturers Association (NEMA) 1991-1993, member 1989-1994.
National Cancer Institute, Radiation Research Program, 1985-1989. Managed contracts and grants for research in radiation oncology.
FDA, Center for Devices and Radiological Health, 1978-1985.
Chief, Radiation Therapy Branch, and Deputy Director, Division of Professional Practices
Directed programs in education and quality assurance for health care professionals. Reviewed 510(k) and PMA submissions in radiation therapy. Reviewed corrective action plans for reported malfunctions and health hazards for a variety of medical devices.
U.S. Navy, 1970 to 1978. Clinical medical physics in radiation oncology, diagnostic radiology & nuclear medicine in Naval Medical Centers.
U.S. Navy, 1966-1970. Performed radiation protection and health physics services.
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