Scott Edwards

Background

About Scott Edwards

Accomplished and results-focused professional with expertise in global operations management, organizational leadership, and strategic relationship/partnership management. An innovative thinker with capabilities in performance management, service delivery, team development and strategic business growth. Articulate written and verbal communicator, able to oversee business intelligence, manage budgets, and control revenue. A vital contributor in company growth with experience in highly visible roles working with VP and C-Level executives. Core Competencies include: Global Clinical Evaluation Plan / Report (CER / CEP) program management, EU MDR Change Management, Organizational Leadership, Strategic Planning, Project Management, Quality System Remediation, Global Quality Systems & Regulations Compliance, Complaint Handling, 21 CFR 803, 806, & 820, ISO 13485:2003-2016, ISO 14971, EU MDR (2017/745), CAPA, Risk Management, Design Control, Continuous Improvement, People Development, 510(k) development, Technical Dossiers, and Industry Best Practices. Technical Specialties include: Medical Device Design and Commercialization, Quality System Design, Implementation, and Remediation, FDA/EU MDR Regulation Compliance, and Metrics Development.