Andres Holle
Sr Director, Regulatory Affairs, Care Solutions @Baxter International Inc.
North Haven, CT, US
EMAILS
a••••••••@baxter.com
MOBILE NUMBERS
+12•••••••86
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WORK HISTORY
May 2022 — Present
Sr Director, Regulatory Affairs, Care Solutions @Baxter International Inc.
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EDUCATION
1994 — 1996
University of New Haven
MS, Env. Science
1987 — 1991
Clark University
Bachelor of Arts (B.A.), Biology, General
SKILLS
Process ImprovementRegulatory SubmissionsSopValidationClinical TrialsIso 13485Design Control21 Cfr Part 11GmpMedical DevicesCapaRegulatory AffairsQuality AssuranceLife SciencesPmaGlpRegulatory RequirementsQuality SystemHardware DiagnosticsFdaStandard Operating Procedure (Sop)U.s. Food and Drug Administration (Fda)Ce MarkingIso 14971Verification and Validation (V&V)Corrective and Preventive Action (Capa)V&VLifesciences
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