Senior EU MDR Clinical Evaluation Consultant

About the role

Clinova CRO is looking for an experienced, hands-on medical-device clinical-evaluation specialist for a defined EU MDR documentation update covering 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 the source-referenced clinical evidence gap register.
• Plan and document systematic literature searches, screening, critical appraisal and state-of-the-art (SOTA) analysis.
• Assess completed device-specific PMCF evidence, PMS/PSUR and vigilance findings, including data limitations and benefit-risk implications.
• Reassess equivalence arguments against direct-device clinical evidence and current intended-purpose claims.
• Prepare controlled, traceable updates to the CEP and CER with evidence tables, source references and proportionate conclusions.
• Support expert/QA review, issue resolution and up to two consolidated client comment cycles.

Required profile

• Personally authored or substantially updated multiple CEPs and CERs under Regulation (EU) 2017/745, with demonstrable deliverables.
• Ideally 5+ years of relevant professional experience and a biomedical, medical, clinical, pharmaceutical, regulatory-science or life-sciences background.
• Preferred: prior work on Class IIb devices, ECG/Holter/cardiac monitoring, Notified Body questions and complex CEP/CER updates.

Required skills

• Strong working knowledge of MDR Article 61 and Annex XIV, MDCG guidance, MEDDEV 2.7/1 Rev. 4 principles and PMS/PMCF/PSUR interfaces.
• Systematic literature search, clinical data appraisal, benefit-risk assessment and document control.
• Sound judgment on statistical claims and evidence limitations.

Estimated effort is about 60-80 hours over 4-5 weeks, depending on source readiness and agreed kickoff. Applicants should send a CV, a short summary of their own EU MDR CEP/CER work and an anonymized example or outline, earliest availability, expected hours and an indicative fee or hourly rate.