Robert Ezzell Jr.'s Linkedin Analytics

Accomplished Regulatory & Quality professional with expertise in drug and medical device regulatory submissions and post-market compliance. Proven ability to use scientific knowledge for insightful quantitative analysis, and to deliver innovative solutions in deadline-driven business environment. Qualifications highlights: • Working knowledge of FDA regulations, EU Directives and compliance with International Standards is advantageous for preparing successful submissions and maintaining regulatory compliance throughout the product lifecycle. • Responsible for compliance with International Standards (IEC 60601 3rd Ed, IEC 62304, IEC 62366, ISO 10993), and International Conference on Harmonization (ICH) E6 Guideline for Good Clinical Practice. • Mobile Medical Devices - including FDA and FCC regulatory requirements for wireless and cellular connectivity, and validation of cloud storage of patient data. • Risk Management - ISO 14971 and Corporate Risk Assessment Initiatives (Product Security Risk Assessment and Privacy Impact Assessment). • Responsible for audits of contract manufacturers and vendors to ensure compliance with FDA Quality System Regulations, ISO 13485 and Corporate Quality Agreements. • Project Management and Leadership skills to align regulatory requirements with business objectives, and leverage relationship with regulatory, clinical and quality to effectively work together and meet aggressive time lines. • Outstanding biomedical research and publication record at Harvard Medical School, MIT and UC Berkeley.