Regulatory Writer: PMCF Survey Protocol & CSR Medical Writer

About the role

Role Summary Support the development of Post-Market Clinical Follow-up (PMCF) survey protocols and Clinical Study Reports (CSRs) to generate and document Level IV clinical evidence for medical devices in compliance with EU MDR requirements.

What you'll do

• Develop PMCF survey protocols, including study objectives, endpoints, methodology, inclusion/exclusion criteria, data collection plans, and analysis approach
• Design survey questionnaires and other tools for collection of real-world, post-market clinical data
• Generate and evaluate Level IV evidence from PMCF surveys, physician/user feedback, and observational post-market data to support device safety, performance, usability
• Analyze survey results and prepare Clinical Study Reports (CSRs) with clear presentation of methodology, findings, conclusions, and limitations
• Support PMCF Evaluation Reports (PMCFERs), Clinical Evaluation Reports (CERs), PMS Reports, PSURs, and benefit-risk assessments

What you need

• Clinical research
• Documentation
• Communication