Brian Johnson
Quality & Regulatory Affairs | Medical Devices and SaMD
- Role
- Senior Regulatory Affairs Specialist at Canary Medical Inc
- Location
- Rock Hill, SC, US
- LinkedIn followers
- 500 followers
About Brian Johnson
I help launch and support Medical Devices and SaMD\'s in the US, EU, Canada, Australia and ROW. I am currently directing regulatory strategy in the US and other markets for a Class II implantable medical device with Software as Medical Device (SaMD) components. I have experience preparing 510k submissions in the US, MDR/IVDR submissions for the EU, and regulatory submissions to bring medical devices to the market in Canada, Australia, Japan, and some South American countries. My most recent focus has been SaMD and software development compliance with IEC 62304, IEC 62366, and AAMI TIR45:2012. As a leader I have built teams and led teams. As a contributor I enjoy collaborating with people across different departments in an organization and I am passionate about lifting people up and improving processes.
Experience
Senior Regulatory Affairs Specialist
Sep 2022 — Present · US
Education
Winthrop University
BS, Biology Minor in Chemistry
1994 — 1999
BSI Training Academy
Certificate, Medical Devices Quality Management Systems ISO 13485:2016, Passed
2019 — 2019
Carolinas College of Health Sciences
MT ASCP, Medical Technology
2000 — 2001
AQS Solutions
Drug GMP Internal Auditor (ASQ), 21 CFR Parts 210 & 211, Passed
2019 — 2019
RAPS
Certificate, Software as a Medical Device
2021 — 2021
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