Emmet Frawley
About Emmet Frawley
Emmet Frawley serves as the Director of Quality & Regulatory Affairs at Luminate Medical, bringing over 25 years of experience in the medical devices sector. He has a strong background in quality systems, regulatory approvals, and team management.
Work at Luminate Medical
Emmet Frawley serves as the Director of Quality & Regulatory Affairs at Luminate Medical, a position he has held since 2023. In this role, he oversees quality assurance and regulatory compliance for medical devices. His responsibilities include ensuring that products meet stringent regulatory standards and managing quality systems within the organization. Frawley's expertise in international regulatory affairs and quality systems is crucial to the company's operations and product development.
Education and Expertise
Emmet Frawley has a solid educational background in engineering and management. He earned a Bachelor of Engineering (BEng) and studied Management at the University of Limerick. He also completed a Diploma in Project Management at the Institute of Project Management. Additionally, he participated in the Medical Devices & Diagnostics Future Leadership Programme at the Institute of Leadership and Management, focusing on Biomedical/Medical Engineering. His educational qualifications support his extensive experience in the medical devices sector.
Background
With over 25 years of experience in senior management roles, Emmet Frawley has worked in both start-up and multinational companies within the medical devices sector. Prior to his current role, he was the Plant Quality Manager at Medtronic from 2019 to 2023 in Galway, Ireland. His background includes significant experience in clinical investigation, risk management, and due diligence, which enhances his capability in managing quality and regulatory affairs.
Achievements
Emmet Frawley has played a key role in the initial certification of several quality systems in the medical devices industry. He successfully managed the international regulatory approval of Class II and Class III products, including orthopaedic, cardiovascular, biodegradable, and vascular devices. His experience also includes managing significant changes such as high growth, critical product introductions, and quality system upgrades, demonstrating his capability in navigating complex regulatory environments.
Professional Skills
Emmet Frawley specializes in device-drug combination products, quality systems, and international regulatory affairs. He is experienced in programme management, technology transfer, and lean methodologies. Known for building and motivating teams, he focuses on achieving demanding targets and fostering a collaborative work environment. His leadership skills are complemented by his technical knowledge in medical devices, making him a valuable asset in the industry.