Regulatory Writer: PMCF Survey Protocol & CSR Medical Writer

Job Description: Regulatory Writer: PMCF Survey Protocol & CSR Medical Writer

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.

Key Responsibilities:

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  Develop PMCF survey protocols, including study objectives, endpoints, methodology, inclusion/exclusion criteria, data collection plans, and analysis approach.
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  Design survey questionnaires and other tools for collection of real-world, post-market clinical data.
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  Generate and evaluate Level IV evidence from PMCF surveys, physician/user feedback, and observational post-market data to support device safety, performance, usability, and clinical benefit.
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  Analyze survey results and prepare Clinical Study Reports (CSRs) with clear presentation of methodology, findings, conclusions, and limitations.
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  Support PMCF Evaluation Reports (PMCFERs), Clinical Evaluation Reports (CERs), PMS Reports, PSURs, and benefit-risk assessments.
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  Perform literature reviews and evidence assessments to support study rationale and interpretation of findings.
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  Collaborate with regulatory, clinical, biostatistics, and client stakeholders and address review comments through document finalization.
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  Ensure compliance with EU MDR 2017/745, MEDDEV 2.7/1 Rev. 4, MDCG guidance, ISO 14155, and internal quality processes.

Qualifications

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  Advanced degree in Life Sciences, Pharmacy, Biotechnology, Biomedical Sciences, Public Health, or related field.
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  Experience in medical writing, clinical evaluation, PMCF, CER, clinical research, or medical device regulatory documentation.
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  Strong scientific writing, literature review, data interpretation, and stakeholder communication skills.
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  Knowledge of PMCF, CER, PMS, PSUR, real-world evidence (RWE), and medical device regulatory requirements.