John Roche

Background

About John Roche

Highly disciplined diagnostics industry leader with global experience and proven track record in leading technology partnering, product development, quality management, and regulatory affairs while improving performance, managing risks, and efficiently deploying resources. Desire to transition from Executive Consultant into Management in a role that drives growth through principled, fact-based, and data driven management style that inspires, excites, and empowers.* Program Management – Product Development Biomedical Engineer focused on creation of diagnostic products. Develop complex medical devices with a focus on system engineering, usability, and opportunity assessment. Technical Due Diligence expert. Manage complex, interdisciplinary, multi-partner programs.* Product Strategy and Partnering – Product positioning, business case, and contracting advisory. Liaison with investors and partner companies’ M&A and Business Development groups. Target identification and deal strategy for supply, development, and distribution agreements.*Regulatory Affairs – Comprehensive knowledge of US FDA, Health Canada, and EU regulations. Created and executed several dozen regulatory strategies and submissions. Specialize in Point of Care and CLIA waiver. FDA Pre-sub advisory and representation.* Quality Assurance – Extensive experience with 21 CFR 820 and ISO 13485. Successfully implemented compliant quality management systems for 10+ startup companies and run QA organizations for established players. Expertise in ISO / FDA / Vendor audits.