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Joe Braido

Senior Director @Merz Therapeutics

Chicago, IL, US
EMAILS
[email protected]
MOBILE NUMBERS
+12•••••••60

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WORK HISTORY

Jan 2020 — Present

Senior Director @Merz Therapeutics

RA Leader for European Medical Device Regulation (MDR) compliance • Provide global regulatory strategies to site leads and senior leaders • Author PMA Supplements and Class EU Design Dossiers for Lifecycle Management purposes • Perform RA impact assessment for broad range of product/process changes • International Regulatory Marketing Authorization lead

SKILLS

GcpFda 483 Responses21 Cfr 210 & 211Training DeliveryIso 13485Medical Devices21 CfrClinical Development510 (K)SAseptic ProcessingManufacturingIso 14971Us Reg Affairs CertificationGmpRisk ManagementValidationRegulatory AffairsIso21 Cfr 820PmasRegulatory RequirementsSupplier ManagementQuality AssuranceQuality ManagementSoftware DocumentationPurchasing ControlsPharmaceuticalsFdaContinuous ImprovementSupplier QualityChange ControlSupply ManagementGlpCe MarkingPharmaceutical IndustryQuality AuditingGxpSop21 Cfr Part 11Global Regualtory Strategies

ABOUT JOE BRAIDO

Strategic Regulatory/Quality visionary with 25 years of proven leadership experience, and…

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