About the assignment
Clinova CRO is seeking an experienced, hands-on medical-device clinical-evaluation specialist for a defined EU MDR documentation update. The assignment covers an existing Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) for an ambulatory ECG monitoring device. Work is remote; Morocco-based applicants are preferred and qualified Europe-based consultants are welcome.
Key responsibilities
• Critically review the existing CEP/CER and source-referenced clinical evidence gap register.
• Plan and document current systematic literature searches, screening, critical appraisal and state-of-the-art (SOTA) analysis.
• Assess completed device-specific PMCF investigation evidence, PMS/PSUR and vigilance findings, including data limitations and benefit-risk implications.
• Reassess existing equivalence arguments against available direct-device clinical evidence and the current intended-purpose claims.
• Prepare controlled, traceable updates to the CEP and CER with evidence tables, source references and proportionate clinical conclusions.
• Support multidisciplinary expert/QA review, issue resolution and up to two consolidated client comment cycles.
Essential experience
• Personally authored or substantially updated multiple medical-device CEPs and CERs under Regulation (EU) 2017/745, with demonstrable deliverables.
• Strong working knowledge of MDR Article 61 and Annex XIV, applicable MDCG guidance, MEDDEV 2.7/1 Rev. 4 principles, and PMS/PMCF/PSUR interfaces.
• Practical systematicliterature search, clinical data appraisal, benefit-risk, and document-control skills; sound judgment around statistical claims and evidence limitations.
• Relevant biomedical, medical, clinical, pharmaceutical, regulatory-science or life-sciences background; ideally 5+ years of relevant professional experience.
Preferred
Prior work on Class IIb devices, ECG/Holter/cardiac monitoring, Notified Body clinical-evaluation questions, and complex CEP/CER updates is a strong advantage.
Engagement and application
Estimated effort: approximately 60–80 hours across 4–5 weeks, subject to source readiness and agreed kickoff. Please send a CV, short summary of personally authored EU MDR CEP/CER assignments, an anonymized/redacted example or outline if permitted, earliest availability, expected hours and indicative project fee or hourly rate.
