Maureen Johnson

Maureen Johnson is a research nurse and medical writer with a unique combination of expertise in regulatory submissions, compliance, and post-market surveillance. With 30 years of regulatory experience including a long tenure at ClinReg Consulting Services, she has prepared IDEs, 510(k)s, and PMAs and authored 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 the post-market surveillance area, Ms. Johnson has extensive experience in global adverse event reporting and complaint management where she has been instrumental in setting up eMDR reporting systems and customer feedback systems, preparing standard operating procedures, writing MDR position papers, and training companies on post-market regulations. Her regulatory compliance experience includes recalls/field corrections, clinical inputs for hazard analyses, CAPAs, and health hazard evaluations/health risk assessments.