Bob Schrader

About Bob Schrader

I am an experienced quality and regulatory leader within the medical device and in vitro diagnostic industries. I have extensive experience improving quality management systems and processes including, but not limited to corrective and preventive action (CAPA), nonconforming product, complaint management, management review, internal/external audit, supplier quality, non-clinical testing, verification and validation. I specialize in guiding organizations through the seemingly complex process of bringing innovative medical devices and in vitro diagnostics (IVDs) to market. My expertise spans the entire product development lifecycle from initial concept and regulatory strategy to regulatory approval, commercialization and post-market activities. I have extensive experience managing cross-functional teams as a project manager, but also as a technical expert. Expertise includes, but is not limited to: Establishment registration | Design Controls | ISO 13485 | ISO 14971 | Cross-functional Collaboration | Feasibility Studies | Regulatory Strategy | Regulatory Roadmap | Chemistry | Product Development

Experience

1. Associate Director of Medical Device Operations Us & Canada

   PQE Group

   Jan 2024 — Present · Buffalo, NY, US

   Subject-matter expert on medical device regulatory strategy and quality systems compliance, while simultaneously leading a cross-functional team of medical device SME\'s to various client projects. Services executed include, but are not limited to:+ Design control assessment and remediation [21 CFR 820.30]+ Prepare, review and assess 510(k) submissions; eSTAR + Device classification & regulatory strategy + Support FDA communications [Pre-submissions(Q-sub)]+ Support establishment registration & device listings [FURLS & DRLM]+ Support foreign and domestic small-business determination application [SBD]+ Risk assessment creation, gap assessment & remediation + Laboratory Developed Test (LDT) preparation and assessment of LDT new ruling + Unique Device Identifier (UDI) compliance [GUDID, GS1]+ Complaint Management & adverse event reporting + Quality audits and efficiency assessments [ISO 13485, MDSAP, etc.]

Education

• University at Buffalo

  Bachelor of Science - BS, Medicinal and Pharmaceutical Chemistry

Skills

• Chemical Data Analysis
• Laboratory Skills
• Iso 9001
• Microsoft Excel
• Teamwork
• Typing
• Analysis
• Inventory Management
• Technical Writing
• Chemistry
• Customer Service
• Training
• Testing
• Quality Assurance
• Troubleshooting
• Microsoft Office
• Research
• Iso 13485
• Microsoft Word