KALMAN MAGYAR, RAC

Consultant to Medical Device and Pharmaceutical Clients in domestic and international Regulatory Affairs, Regulatory Compliance, Clinical Research, Project Planning, Research & Development, Due Diligence Studies, Market Feasibilty Evaluations and Busienss Development.

Medical Technologies Group (1990-1999)

Associate Director, Corporate Regulatory and Government Affairs/Regulatory Compliance

Responsible for coordinating, developing and implementing corporate regulatory policies for the divisions worldwide. Troubleshoot, evaluate and assure compliance to regulations and internal standards. Interface with all U.S. and international divisions.

Manager, Regulatory Affairs

Reported to President. Established and managed a strategic Regulatory Department and achieved complete integration with Clinical Research, Product Development and Marketing. Prepared numerous product submissions and obtained approvals worldwide. Successfully coordinated defense against FDA to remove a vital product from the market. Developed complete compliance system for company. Handled practically all communications with FDA and other regulatory agencies worldwide. The company marketed invasive and noninvasive devices for the orthopedic market.

Manager, Regulatory Affairs

Responsibilities included development, implementation and management of worldwide clinical and regulatory activities. Established a Regulatory Department, prepared all regulatory submissions and managed the approval process. Handled correspondence with Regulatory agencies worldwide, including FDA. Regulatory Consultant and Strategic Planner to R&D, Marketing and Manufacturing. The company marketed mostly cardiovascular devices.

Senior Project Coordination Manager, Drug Registration and Regulatory Affairs (1979-1984)

Independently coordinated, planned and managed all R&D activities for assigned projects for marketed and new pharmaceutical products. Coordinated assembly of regulatory submission to FDA and handled all communications and follow-up actions between company and FDA. Successfully coordinated regulatory approvals of new products and addition of new indications for already approved products. Assured smooth interface among Marketing, R&D, Manufacturing, Product Development and Regulatory agencies. Assisted in SBU (Strategic Business Unit) development requiring international communications and coordination.

Clinical Research Associate, Clinical Research Department (1976-1979)

Set up, managed and concluded clinical studies for several new and already marketed drugs. Prepared protocols, clinical summaries and conducted all communications for the company with clinical investigators.

Analytical Chemist, Drug Metabolism Department (1972-1976)

Developed and adapted new analytical techniques to determine concentrations of drugs in biological fluids. Supervised and managed the analysis of large sample load drug metabolism studies.

Forensic Chemist, U.S. Government

Analyzed and determined controlled substance content of drug seizures. Developed appropriate essays to allow analysis of samples. Offered expert witness testimony at legal proceedings.

Quality Control Chemist

Analyzed raw materials, intermediate and finished products for purity according to strict company and government standards.

EDUCATION

PUBLICATIONS

Liquid-Solid Chromatographic Determination of 6-Desmethylgriseofulvin in Urine
E. Papp, K. Magyar, H.J. Schwarz

Journal of Pharmaceutical Sciences, Vol. 65, No. 3, March 1976, pp. 441-443

Vacuum Searches in Narcotic Cases
J.A. Fasanello, R. A. Anderson; (Magyar acknowledgement)

Journal of Forensic Sciences, Vol. 19, No. 2, 1974, pp. 379-383

PROFESSIONAL ORGANIZATIONS AND INDUSTRY GROUP INVOLVEMENT

Regulatory Affairs Professionals Society (RAPS)

Health Industry Manufacturers Association (HIMA)

American Society for Quality (ASQ)

Association for the Advancement of Medical Instrumentation (AAMI)

Association for Food and Drug Officials (AFDO and CASA)