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.

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