Angela Estany
Sr Director, Regulatory Affairs, Quality and Compliance @Thermo Fisher Scientific
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WORK HISTORY
Sr Director, Regulatory Affairs, Quality and Compliance @Thermo Fisher Scientific
EDUCATION
California State University, Los Angeles
Master of Science (M.S.), Biology, General
California State University, Los Angeles
Bachelor of Science (B.S.), Biology, General
ABOUT ANGELA ESTANY
Over 19 years experience in the Quality Assurance and Regulatory Affairs field with extensive knowledge of cGMP’s, GLP’s, federal/state/local and international regulations including ISO 13485, IVDD 98/79/EC & MDD 93/42/EC. Demonstrated talent for identifying, analyzing and solving problems. Excellent communication and interpersonal skills. Proven ability to multi-task, organize and follow through with all activities affecting product and service quality.Highlights • Responsible for the domestic and international regulatory clearance of over 10 Class II medical devices including software medical devices. • Responsible for establishing and launching electronic Quality Systems.• Notable participant in the CFDA International Regulatory Affairs Forum for Medical Devices.• Several hundred hours with hands on regulatory inspections, including FDA and Notified Bodies. • Key integration leader during company acquisitions, including due diligence and transferring of manufacturing facilities and regulatory licensure.• Responsible for implementing and managing robust import/export compliance program; earning Outstanding Contributor Award.
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