Jonathan Day
Sr Director Regulatory Affairs @SOPHiA GENETICS
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WORK HISTORY
Sr Director Regulatory Affairs @SOPHiA GENETICS
Vaud, CH
EDUCATION
King's College London
BSc Hons, Microbiology
ABOUT JONATHAN DAY
Business Development/Regulatory Affairs/StrategyWorking knowledge of EU IVD, MD directives (including 93/465/EEC), and emerging market medical device legislation. Experienced in providing strategic input through regulatory road mapping and identification of new market opportunities for novel technologies. Full working knowledge of FDA QSR 21 CFR 820, ISO 13485 standards.• Management/Project ManagementSuccessful technology transfer of new products, successful management of cGMP, manufacturing practices and documentation remediation team. Creation, maintenance and presentation of metrics to evaluate team performance.• Supply Chain ManagementWorking knowledge and hands on experience of planning, scheduling, use of ERP/MRP systems relative to the production of DNA/RNA, protein translation, and cGMP IVD assays/biosensors. Author high level interdepartmental SOPs. Investigation of assigned customer complaints. Identify, troubleshoot and improve deficiencies in manufacturing processes.• TrainingChange management, communication/conflict management, project management, team leadership and team dynamics, writing (executive summaries, justifications and SOPs), Lean manufacturing principles, IOSH, Auditing. TOPRA membership.Speaking Invitations:2nd Annual IVD Regulations and Performance Evaluations Conference, Brussels Feb 6th-7th 2012;\"Home Brewed Diagnostics: Guidance on Regulations and Performance Evaluations\"Imperial College Biomedical Electronics Nov 2012 Guest Lecturer
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