Michael Schwartz

Background

About Michael Schwartz

SENIOR EXECUTIVE LEADER Advancing Global Medical Trials with Excellence in Regulatory Compliance & Team Leadership Clinical Research leader directing global clinical operations across the medical device, biotech, and pharmaceutical sectors. Expert in strategic development, comprehensive clinical trial management, regulatory compliance, and cross-functional leadership. Renowned for building high-performance teams, optimizing trial operations, securing regulatory approvals, reducing timelines, and mitigating risks. Extensive experience with 510(k), IDE, and PMA applications under FDA, ICH/GCP, and ISO regulatory frameworks. Champion international teams through numerous global clinical trials, ensuring operational excellence, risk mitigation, and stringent compliance with regulatory authorities. Driven, innovative, collaborative, and adaptable professional committed to advancing clinical research and improving patient outcomes. • Clinical Operations Leadership (Global Clinical Trials, Therapeutic Focused Groups, CRO, and Vendor Oversight) • Regulatory Compliance & Strategy (ISO 14155, ICH/GCP, MDR) • Team Development & Mentorship (Hiring, Training, Performance Optimization, Therapeutic Areas) • Quality Assurance & Regulatory Compliance (Clinical Operations/KPI Compliance Monitoring Program Development/Leader, ICH/GCP Governance, Maintain Regulatory Inspection Readiness; Quality System, and Document Management) • Process Improvement & Risk Mitigation (Full responsibility for SOPs covering all Clinical Operations/Departments, CAPA Governance/Leader with Root Cause Analysis, Portfolio Risk Management, and Mitigation across Phase I-IV trails) • Financial & Business Acumen ($80M+ Business Development Success, Budgeting and Forecasting, Portfolio and Enterprise strategic Planning, Staffing, and Personnel Development) • Stakeholder & Executive Engagement (C-Suite Reporting, Client Relations) Mr. Schwartz has direct experience with CFR 312 (IND), 314 (NDA), 56 (IRB), 54 (FD), 50 (ICF), 803, 812 (IDE), 814 (PMA/510k), ISO 14155, ISO13485, GCP/GMP, MDR, and ICH guidelines. Specialties: Well versed in- 21 CFR Parts 11, 50, 54, 56, 312, 314, 803, 812, 814, 822 - ICH/GCP E6, E2A, E8 - Related FDA Guidance Documents - ISO 14155:2020, ISO13485:2016 - Early Feasibility, Pilot, Pivotal, and Post-Market, International Trials - Phase I-IV Trials, Single and Multi-Center, International - Early Feasibility, Pilot, and Pivotal, Post-Market Surveillance, and Registry - HCP Interaction (AdvaMed)- HIPPA / HITECH compliance - CMS Reimbursement