Alison Sathe
Senior Vice President, Medtech @Redica Systems
Cincinnati, OH, US
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MOBILE NUMBERS
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WORK HISTORY
Apr 2022 — Present
Senior Vice President, Medtech @Redica Systems
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Redica Systems is a data and software company that provides regulatory and quality intelligence to FDA-regulated industries. The company serves 200+ pharmaceutical and medical device firms, helping them stay ahead of global regulatory changes, access extensive enforcement and inspection intelligence, monitor supplier risk, and improve team collaboration.
SKILLS
Regulatory AnalysisRegulatory ComplianceFederal & State Regulatory ComplianceFda GmpCapaQuality AuditingRegulatory Strategy DevelopmentRegulatory RequirementsGlobal Regulatory ComplianceClinical ResearchQuality SystemsStrategyFdaQuality SystemVerification and Validation (V&V)U.s. Food and Drug Administration (Fda)Validation21 CfrIso StandardsClinical TrialsRegulatory AuditsCe MarkingRegulatory GuidelinesRegulatory FilingsDesign ControlRegulatory DocumentationBiomedical EngineeringV&VR&DRegulatory SubmissionsIsoRegulatory RiskProduct DevelopmentCross-Functional Team LeadershipIso 13485Iso 14971Regulatory PolicyBiotechnologyQuality AssuranceRegulatory Affairs
ABOUT ALISON SATHE
Experienced Regulatory and Clinical Affairs consultant for medical technology with…
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