Rey Restrepo

WORK HISTORY

SKILLS

ABOUT REY RESTREPO

EXECUTIVE SUMMARYSeasoned Quality Assurance and Regulatory Affairs executive with over 25 years of progressive leadership in the medical device industry, spanning FDA Class II and Class product portfolios. Demonstrated success in shaping and executing global quality strategies, strengthening regulatory compliance, and elevating product reliability and patient safety across multi-site, multinational operations.A trusted senior leader with experience as Vice President and Senior Director, overseeing enterprise-wide Quality Management Systems, Design Assurance, Risk Management, Post-Market Surveillance, Complaint Handling, Supplier Quality, and Audit Readiness. Expert in leading organizations through FDA inspections, Notified Body audits, EU MDR transitions, large-scale QMS transformations, M&A integration, and high-growth startup environments.Known for building and developing high-performing global teams, driving operational excellence, and fostering a culture of accountability and continuous improvement. Adept at partnering with executive leadership, R&D, Operations, and Regulatory stakeholders to ensure robust compliance, accelerate innovation, and enable the delivery of safe, effective, and high-quality medical devices to patients worldwide.Expertise: Quality Systems (21 CFR 820 | ISO 13485 | ISO 9001 | ISO/TS 16949)| Quality & Regulatory Strategy | Regulatory Submissions & Approvals | FDA Audits/483s/Warnings/Remediation | Audits | Recalls | Validations | EU MDR | Risk Management (ISO 14971:2019)| New Product Development | Project Management | Training | International Supply Chain Sourcing & Management | CE Mark | Import/Export Detentions | Clinical Trials | Market Research | Privacy & Security (ISO/IEC 27701)