Brian Johnson
About Brian Johnson
Brian Johnson is a Senior Regulatory Affairs Specialist with extensive experience in regulatory compliance and quality assurance across various organizations in the medical technology field. He currently works at Canary Medical Inc. and has held previous positions at Monarch Medical Technologies, CSL Plasma, and LifeScan, among others.
Work at Canary Medical
Brian Johnson serves as a Senior Regulatory Affairs Specialist at Canary Medical Inc. since 2022. In this role, he focuses on ensuring compliance with regulatory standards and guidelines. His responsibilities include supporting the audit program with an emphasis on regulatory aspects and participating in both internal and external audits. He also coordinates the review of promotional materials to ensure they meet regulatory requirements. Johnson plays a significant role in supporting adverse event assessment and reporting to regulatory authorities.
Previous Experience in Regulatory Affairs
Before joining Canary Medical, Brian Johnson held various positions in regulatory affairs and quality systems. He worked at Monarch Medical Technologies as a Senior Regulatory and Compliance Specialist from 2019 to 2021. Prior to that, he was a Senior Regulatory Affairs Specialist at LifeScan from 2021 to 2022. His experience also includes serving as a Quality Systems Supervisor at CSL Plasma from 2016 to 2019 and as a Quality Assurance and Regulatory Affairs Specialist at HARTMANN USA, Inc. from 2013 to 2016.
Education and Certifications
Brian Johnson holds a Bachelor of Science degree from Winthrop University, where he studied Biology with a minor in Chemistry. He has also achieved several certifications relevant to his field, including a certificate in Software as a Medical Device from RAPS in 2021, and a certificate in Medical Devices Quality Management Systems ISO 13485:2016 from BSI Training Academy. Additionally, he studied 21 CFR Parts 210 & 211 at AQS Solutions and earned the Drug GMP Internal Auditor (ASQ) certification.
Expertise in Regulatory Submissions
Brian Johnson has expertise in preparing regulatory submissions for multiple international markets, including Japan and certain South American countries. His knowledge extends to software development compliance with standards such as IEC 62304, IEC 62366, and AAMI TIR45:2012. This expertise is critical in ensuring that products meet the necessary regulatory requirements for market entry and compliance.
Background in Quality Assurance
Brian Johnson has a substantial background in quality assurance, having worked in various roles throughout his career. He began at the American Red Cross, where he held multiple positions, including Quality Control Specialist and Validation Associate, from 2001 to 2006. He also served as a Lead Validation Specialist at Leiner Health Products for one year. His extensive experience in quality systems and regulatory affairs has equipped him with the skills necessary to navigate complex regulatory environments.