Audrey Vitale

Ms. Vitale has 17 years of experience in medical device regulation, including product approvals in the US and EU, and quality system compliance with ISO 9001, ISO 13485, EU Medical Device Directive, and FDA Quality System Regulation.

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Ms. Vitale joined LifeScience PLUS after 9 years as Regulatory Affairs Director for Ultracell Medical Technologies, an ophthalmology and ENT device manufacturer, where she was responsible for regulatory affiars, quality assurance, product and manufacturing validation, and quality system development and compliance. Prior to working in the medical device field, Ms. Vitale was a process engineer for Corning, Inc. in their optical fiber manufacturing division. Ms. Vitale has a B.S. in Materials Engineering from Rensselaer Polytechnic Institute, and is a member of the Regulatory Affairs Professional Society, with certification in US Regulatory Affairs.