Mridi Wehls
Associate Director @Shockwave Medical
San Francisco, CA, US
EMAILS
MOBILE NUMBERS
+91 *********19
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WORK HISTORY
Sep 2023 — Present
Associate Director @Shockwave Medical
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Santa Clara, CA, US
EDUCATION
N/A
The Johns Hopkins University
Master of Science (MS), Biotechnology (Concentration: Regulatory Affairs)
N/A
The University of Utah
Bachelor of Science (B.S.), Biomedical Engineering
SKILLS
Product ValidationFdaLean ManufacturingCe MarkingProduct DevelopmentRoot Cause AnalysisQuality SystemV&VIso 13485Organizational LeadershipQuality EngineeringCqeQuality System RegulationsQuality AuditingBiomedical EngineeringQuality AssuranceDesign for ManufacturingQuality ControlGmpDesign ControlTechnical WritingStrategic PlanningRegulatory SubmissionsValidationBiomaterialsSupplier QualityIso 14971Certified Quality Engineer (Asq)Asq Certified Quality AuditorProcess ValidationFmeaQsrProject PlanningSpcMedical Device Product DevelopmentCqaU.s. Food and Drug Administration (Fda)Design of ExperimentsCanadian Medical Device RegulationsMedical Devices
ABOUT MRIDI WEHLS
RAC certified regulatory professional. Highly proficient in global regulatory strategy development, 510(k)s, PMAs, MDR & IVDR Technical Files, advertising and promotion. Experienced in a wide variety of medical devices including implants, single use, capital equipment and software, in vitro diagnostics.
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