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Vesna Socava-Lile

Staff Quality Specialist - Regulatory Compliance @iRhythm Technologies, Inc.

Portland, ME, US
EMAILS
v••••••••@irhythmtech.com
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jan 2025 — Present

Staff Quality Specialist - Regulatory Compliance @iRhythm Technologies, Inc.

EDUCATION

1996

University of Wisconsin-Parkside

Bachelor of Science, Biological Sciences

SKILLS

Regulatory RequirementsRegulatory AffairsLifesciencesLean ManufacturingClinical TrialsManufacturingCqaSoftware DocumentationQuality Management21 Cfr Part 11Root Cause AnalysisTrackwiseQuality SystemV&VTestingProcess ImprovementLaboratoryGlpValidationSix SigmaGxpFda GmpLimsQuality AuditingAseptic ProcessingInternal AuditR&DQuality ControlGmpIso 13485Medical DevicesCapaDesign ControlCross-Functional Team LeadershipSupplier QualityIso 14971DmaicRegulatory SubmissionsBiotechnologyCe Marking

ABOUT VESNA SOCAVA-LILE

Experienced, deeply collaborative, innovative and effective leader who embraces change and has a passion for compliance. Successfully managed and resolved FDA Consent Decree, multiple FDA Warning Letters across several companies. Provided effective external audit representation and support for announced and unannounced audits. Expert at risk and compliance management, auditing, identification and resolution of risk and compliance gaps, data analysis and metrics. Strong advocate for continuous improvement and streamlining opportunities. High performing, proactive collaborator, able to work with and direct teams and resolve complex issues. Always customer-focused to ensure that our products are safe and effective.

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