Principal Clinical Product Risk Scientist
Current(Principal Clinical Evaluation Scientist)Division- Peripheral Interventions, Interventional Oncology & Embolization Lead & Subject Matter Expert - Global Clinical Evaluation• Leads and authors Clinical Evaluation Reports, Post-Market Clinical Follow-Up Reports, and Plans, serving as the subject matter expert for specific product families and regulatory guidance pertaining to EU MDR and CSR (Canada) clinical risk assessment activities.• Conduct post-market safety signal detection and surveillance activities to identify adverse events, hazards, and benefits, informing the development and updates of Instructions for Use, Hazard Analysis, and other clinical risk-related documents.• Presents Programs to Global and PI Divisional Audiences.AI Change Champion• Primary Aim is to increase AI IQ, scale AI implementation globally, inspire and motivate peers and leaders. Use technology and models to align with core values, inform decisions to enhance and accelerate our work, and communicate the role AI plays in our solutions. Mentor • Mentor and train junior clinical product risk members of the clinical product risk team, serving as a subject matter expert in key clinical evaluation and risk management activities.• Spearhead the development, training, and execution of projects utilizing Distiller Systematic Review Software, enhancing team proficiency and project outcomes.• EmpowHER ERG MentorGlobal Volunteer• BRIDGE ERG Global Co-Lead, 2024 Society of Women Engineers Conference Communications Co-Lead, and EmpowHER ERG Leadership Lean in Circle participant.