Darlene T. Korab

image not available

Darlene T. Korab

Personal Information

Position:Nurse and Regulatory Consultant
Practice Area:
Experience:10 Years
Address:
Phone:888-370-7575
Email:
Fax: 6985231456

Medical Products Consultant
Mission: To support advocacy efforts for clients and their families who seek fair compensation from pharmaceutical and medical device corporations and healthcare providers.

Credentials

  • Regulatory Affairs Certified in US regulations for medical products including pharmaceuticals, medical devices, biologics, and biotechnology
  • Regulatory Affairs Professionals Society (RAPS): international organization of individuals who specialize in the process of developing, introducing, manufacturing, and maintaining safe and effective medical products worldwide
  • Certified by the American Association for Medical Instrumentation in the Quality System Regulation for US Food and Drug Administration (FDA) and Industry

Background

  • Twelve years’ experience as senior project manager and specialist in the field of regulatory affairs for leading international medical device corporations
  • Ms. Korab served as FDA liaison and worked with industry scientists and engineers in the design, development and marketing of medical products, including patient monitors, fluid delivery devices, invasive catheters, and implants.
  • Supervised product liability claims for medical device firms
  • As licensed Florida claims adjuster, handled medical malpractice claims and general liability claims for self-insured hospital systems
  • As college intern, served as Vera Institute of Justice legal representative for Manhattan Criminal Court defendants in New York City
  • Served as team leader, charge nurse and primary caregiver in Labor and Delivery and Maternal-Infant Care Units at Albert Einstein Medical Center, Philadelphia

Education

  • Extensive training in US Federal Food, Drug and Cosmetic Act; US Food and Drug Administration Regulations; European Medical Devices Directive;
  • Medical Product Design, Development, and Manufacture; and Product Liability
  • Bachelor of Science in Nursing, Temple University, President’s Scholar
  • Bachelor of Liberal Arts in Psychology, Antioch College