Raphael E. Judkins

Director, Client Services and Chief Financial Officer

A native New Yorker, Raphael’s professional life has included work for academia, not-for-profit and for-profit organizations. He has had an impressive and successful career in business management, accounting, and regulatory affairs and has worked in these areas for Columbia University Departments of Chemistry and Human Genetics and the March of Dimes. In addition, Raphael is a Certified Lead Auditor for the Food and Drug Administration (FDA) with over twenty years experience in the regulatory industry with a specialty in medical devices and extensive knowledge of regulatory affairs and marketing guidelines of pharmaceuticals. He has full working and interpretative knowledge of the ‘Code of Federal Regulations’ (CFR) and the International Organization of Standardization (ISO). He has written and coordinated a Quality System for full compliance with the both the FDA and ISO regulations.  Raphael is registered with the Registrar Accreditation Board (RAB) and the International Register of Certified Auditors (IRCA).

His regulatory knowledge encompasses all international regulations for product approvals, exporting and importing. He has also secured over 50 product approvals from the FDA for a manufacturing firm and acted as a liaison for FDA inspections. Communication through the written word and orally are invaluable to the success of his regulatory experience. As Manager of Regulatory Affairs for Heraeus Kulzer, Inc., Raphael was the point person for all FDA inspections and International Organization Standardization audits by a third party registrar. He is a member of the American Society of Quality (ASQ), Regulatory Affairs Professional Society (RAPS) and the Institute of Internal Auditors (IIA).

Raphael is also an accomplished public speaker and has worked over four decades as a public speaker instructor and trainer.