Clinical Evaluation

Role Purpose

Lead the end-to-end clinical evaluation and clinical evidence strategy for Class III implantable medical devices in compliance with Regulation (EU) 2017/745 (EU MDR). Own the preparation, review, approval and lifecycle maintenance of Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER), ensuring robust clinical evidence and alignment with post-market surveillance, risk management and product claims.

Key Responsibilities

• Lead preparation, review and periodic update of CEP and CER in accordance with EU MDR Article 61 and Annex XIV Part A, applying MEDDEV 2.7/1 Rev. 4 methodology as appropriate.
• Define clinical evidence strategy and assess clinical safety, performance, clinical benefit, benefit-risk acceptability, intended purpose, indications, claims and State of the Art (SOTA).
• Plan and oversee systematic literature searches, screening, critical appraisal, data extraction and analysis of clinical investigations and scientific literature.
• Establish objective safety and performance acceptance criteria/benchmarks, including acceptable rates or thresholds for adverse events, serious adverse events, device-related complications and undesirable side-effects, based on SOTA, relevant literature, clinical data and benefit-risk considerations.
• Apply appropriate statistical methods to evaluate adverse-event rates and determine/justify acceptance thresholds, including as applicable incidence/proportion estimates, confidence intervals, comparator or benchmark analysis, hypothesis testing, survival/time-to-event methods and trend analysis. Ensure statistical methods, assumptions and thresholds are scientifically justified and documented in the CEP/CER.
• Assess whether observed adverse-event and complication rates remain within predefined acceptance criteria and evaluate their impact on residual risk and benefit-risk acceptability.
• Determine whether clinical evidence is sufficient, identify evidence gaps, and define required PMCF and/or clinical investigation activities. Apply MDCG 2020-6 principles for sufficient clinical evidence for legacy devices, where applicable.
• Integrate and evaluate data from PMS, PMCF, PSUR, vigilance, complaints, registries, literature and clinical investigations throughout the device lifecycle.
• Prepare/review the Summary of Safety and Clinical Performance (SSCP) in accordance with EU MDR Article 32 and MDCG 2019-9 Rev.1, including appropriate presentation of undesirable side-effects/adverse events, their frequencies and relevant clinical outcomes.
• Ensure consistency across CER, SSCP, Risk Management File, PMS, PMCF, PSUR, GSPR, IFU/labeling, intended purpose and clinical claims.
• Lead responses to Notified Body clinical evaluation questions, findings and nonconformities and support clinical evidence discussions during conformity assessment.

Work cross-functionally with Regulatory Affairs, Medical Affairs, R&D, Quality, Biostatistics, Risk Management, PMS/Vigilance, Clinical Operations and external consultants/CROs

Requirements

• Master’s degree or higher in Medicine, Pharmacy, Life Sciences, Biomedical Engineering, Clinical Research, Biostatistics or related discipline; PhD/PharmD preferred.
• 5–8 years of relevant medical-device clinical/regulatory experience, with substantial hands-on experience in Class III and/or implantable devices.
• Demonstrated experience authoring/reviewing EU MDR CERs, defining clinical safety/performance endpoints and acceptance criteria, interpreting statistical analyses, and addressing Notified Body clinical evaluation questions.
• Strong expertise in systematic literature review, SOTA, critical appraisal, clinical statistics, adverse-event analysis, benefit-risk evaluation, PMS/PMCF and scientific writing.

Benefits

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