Open to opportunities

BRIAN JOHNSON

@brianjohnson3

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Quality and regulatory affairs professional specializing in medical devices and pharmaceuticals.

United States

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What I'm looking for

I seek roles where I can lead QMS and regulatory strategy for medical devices/SaMD, drive cross-functional improvements, mentor teams, and apply AI-enabled tools to improve compliance and efficiency.

I am a Quality Assurance and Regulatory Affairs professional with extensive experience in medical device and pharmaceutical manufacturing. I specialize in Quality Management Systems, regulatory compliance, and driving improvements through cross-functional collaboration.

I have led regulatory strategy and compliance for Class II and Class III medical devices and SaMD, managing submissions and maintaining ISO certifications and FDA registrations across multiple regions. I implemented QMS and ALM tools and provided subject matter expertise on AI tools for risk management and regulatory compliance.

My achievements include leading CAPAs that reduced defect and complaint rates, implementing projects that cut scrap and saved substantial costs, and aligning software development with IEC 62304 and Agile practices. I have led audits, supplier quality programs, and post-market activities including adverse event reporting.

I train and lead teams to strengthen QMS processes, develop SOPs and design history files, and ensure ongoing compliance with standards such as ISO 13485, ISO 9001, FDA 21 CFR 820, EU MDR, IVDR, and relevant national regulations.

Experience

Work history, roles, and key accomplishments

Quality and Regulatory Specialist

Matrix Requirements

Jan 2025 - Oct 2025 (9 months)

Implemented a Matrix QMS and ALM tooling for medical device and pharmaceutical clients, configuring SOPs, WIs, design control models and trace matrices while advising on AI tools for risk management and regulatory compliance.

Design Control ALM SOP WI Risk Management Validation Traceability

Senior Regulatory Affairs Specialist

Canary Medical

Sep 2022 - Sep 2024 (2 years)

Led regulatory strategy and compliance for a Class II/III knee implant with tracking software across 4 releases, maintained ISO/MDSAP certifications, and managed post-market reporting and multiple international regulatory submissions.

Regulatory Strategy ISO 13485 MDSAP EU MDR Labeling

Senior Regulatory Affairs Specialist

Lifescan, Inc.

May 2021 - Sep 2022 (1 year 4 months)

Directed global regulatory compliance for a diabetes SaMD (Class B/II) across multiple jurisdictions, supported ISO 13485 and MDSAP audits, and guided design control and risk management for three product releases.

SaMD IVDR EU MDR ISO 13485 MDSAP Regulatory Strategy Training

Senior Quality and Regulatory Specialist

Monarch Medical Technologies

Jan 2019 - May 2021 (2 years 4 months)

Managed QMS and regulatory compliance for Class II diabetes software devices, updated SOPs, improved supplier quality and PDCA processes, aligned SDLC with IEC 62304, and maintained ISO 13485 certification.

SOP Development PDCA Process ISO 13485 Document Control

Quality Systems Supervisor

CSL Plasma

Jan 2016 - Jan 2019 (3 years)

Led a team of six in a blood-collection pharmaceutical facility, executing CAPAs that cut defect rates 75%, reduced scrap 93% saving $242k annually, strengthened QMS and ensured compliance with FDA and ISO standards.

CAPA ISO 13485 Batch Record Review Team Leadership

Quality Assurance & Regulatory Affairs Specialist

Hartmann USA, Inc.

Jan 2013 - Dec 2015 (2 years 11 months)

Implemented QMS improvements and supplier quality metrics at a wound care manufacturing facility, managed design history files and maintained multi-region product listings and FDA site registrations.

Design Files SOPs ISO 9001 Regulatory Submissions Quality

Quality Assurance & Technical Support Specialist

American Red Cross

May 2007 - Jul 2011 (4 years 2 months)

Ensured regulatory compliance for in-vitro diagnostics and blood products, led MRBs and CAPAs to reduce recurring quality issues, and provided technical support across seven laboratories.

CAPA Technical Support