Warren Opfer

Warren Opfer is the President and Principal Consultant at Life Science Services International (LSSI), a veteran-owned corporation established in April 1992, specializing in Quality and Regulatory Compliance Improvement for the medical device, pharmaceutical, and biotechnology industries. With extensive experience as a trusted advisor to C-level executives, Warren has held positions such as Senior SME Consultant at Jabil Healthcare, focusing on computer system validation, and Senior Consultant at RQM+/Maetrics, where leadership in EU MDR gap assessments for Class III implantable products was provided. Additional roles include consulting positions at Becton Dickinson & Company and B. Braun Group, where expertise in risk management and compliance with EU regulations was applied, as well as interim leadership positions in quality systems for medical device manufacturers. Warren holds multiple degrees, including an MBA in Industrial & Production Management/Economics and a BS in Business Management/Computer Science from Wright State University, complemented by education from the University of Strathclyde and NSF seminars.