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.
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