Sme Clinical Consultant
CurrentHighlights of Qualifications• Coordinated with a global, cross-functional team to facilitate timely and accurate assessment of complaints, with specific emphasis in ensuring information was analyzed for determining regulatory reporting requirements.• Generated MDR’s and International Notified Body submissions. • Assessed complaints on-site in Zuchwil, Switzerland, using CATSweb software as the clinical SME of a remediation team.• Provided clinical knowledge of injuries to assist Regulatory Affairs in determining recall requirement, and supported subsequent product recall activities.• Leveraged clinical knowledge and experience to investigate the role of medical devices in reported injuries/deaths.• Provided education on disease states, treatments, and clinical use of devices to regulatory professionals in response to an FDA warning letter.Skills Summary• Root Cause Analysis• Post-Market Surveillance• Remediation• Complaint Handling• Clinical Studies/ Journal Articles• Scientific Literature Review• Critical Clinical Evaluations• GMP Inspection Responses and Recalls- • 483s, Warning Letters & Consent Decrees• Complaint Investigation Compliance- Use of various complaint software programs including EtQ, TrackWise & CATSweb• MDR Submissions/International Notified Body Submissions• Knowledge of FDA QSR regulations -21 CFR 803, 806 & 820• Knowledge of ISO 13485• Product Labeling Review• Clinical Resource/ SME
