Senior Consultant, Halloran Consulting Group
Brian joined Halloran Consulting Group in 2014. He has more than 10 years of experience in regulatory affairs and Quality System development. Brian has experience in creating and implementing Quality Systems in the medical device industry that ensure compliance with ISO 13485 and FDA’s Quality System Regulation. He has a background in software and maintains an expertise in software development activities and Software as a Medical Device. Brian supports remediation projects and leads organizations through FDA inspections with successful outcomes.
Prior to joining Halloran, Brian was the Regulatory Affairs Manager for lifeIMAGE where he developed the quality system and ensured products comply with Food and Drug Administration (FDA) regulatory requirements. While at lifeIMAGE, Brian owned and maintained all aspects of the quality system including documentation control, supplier controls, CAPA process, internal audit programs, complaints, and Medical Device Reporting (MDR). Prior to lifeIMAGE, Brian held various positions at Boston Scientific and Caliper Life Sciences.
Brian earned a Masters of Business Administration and Masters of Science in Management from Babson College near Boston, MA. He earned his Bachelors of Science in Management with a concentration in Management Information Systems from Rensselaer Polytechnic Institute in Troy, NY. Brian also holds his Regulatory Affairs Certification (RAC).