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

• Mobile Bill