Maureen Johnson, RN

Founder, Senior Vice President of Consulting Resources & Program Management
Maureen Johnson is a research nurse and medical writer with 30 years of regulatory experience including a long tenure at ClinReg Consulting before co-founding Regulatory Pathways Group. She specializes in medical device regulatory submissions, regulatory compliance, and post-market surveillance. She has prepared IDEs, 510(k)s, PMAs, EU MDR Applications, and authored key clinical/regulatory documents such as protocols, informed consent documents, case report forms, clinical evaluation reports, systematic literature reviews, state-of-the-art reports, benefit-risk determinations, adverse event summaries, clinical study reports, directions for use, patient brochures, operator’s manuals, device descriptions, and manuscripts. In post-market surveillance, Ms. Johnson has extensive experience in global adverse event reporting and complaint management. She has played a key role in establishing electronic MDR reporting systems and customer feedback systems while guiding companies through complex post-market regulations. Her regulatory compliance expertise includes medical device reporting, recall and field correction strategies, clinical inputs for risk management, CAPAs, health hazard evaluations. Ms. Johnson also serves as an expert witness for litigation cases involving medical device reporting and complaints per 21 CFR § 803 and 21 CFR § 820.198. She earned a bachelor’s degree from the University of California Irvine before completing her clinical training.