Principal, Clinical Research (Clinical Project Lead – PMCF and Lifecycle Management, Instrumentation)

Key Responsibilities: The Principal I, Clinical Project Lead – PMCF and Lifecycle Management, Instrumentation executes post-market clinical follow-up (PMCF) and clinical lifecycle management activities for ophthalmic instrumentation and conducts clinical review of clinical evaluation documentation, ensuring that evidence and documentation are compliant, traceable, and audit-ready. Major Accountabilities (Describe the main results of the job to be achieved) 1.      Plan and execute PMCF activities, including registries, surveys, retrospective analyses, and real-world evidence initiatives, and develop protocols and reports aligned with Regulation (EU) 2017/745 (EU MDR), applicable Medical Device Coordination Group (MDCG) guidance, and internal procedures. 2.      Interpret PMCF findings against device performance, safety trends, state of the art, risk management, and benefit-risk conclusions, and integrate them into applicable post-market surveillance (PMS) and periodic safety update report (PSUR) outputs. 3.      Conduct clinical review of clinical evaluation documentation, including clinical evaluation reports, state-of-the-art assessments, and clinical evidence gap analyses, for scientific rigor, consistency, and traceability. 4.      Assess the clinical impact of product changes, safety signals, and clinical claims to inform benefit-risk assessments, product change assessments, and responses to regulatory, audit, and Notified Body questions as needed. 5.      Contribute to process improvements, templates, and knowledge-sharing practices that improve quality, efficiency, and audit readiness. Key Requirements/Minimum Qualifications: ·       Timely delivery of PMCF outputs and clinical evaluation review feedback against agreed plans. ·       First-pass quality of deliverables and review feedback, including traceability and procedural compliance. ·       Timely identification, escalation, and resolution of evidence gaps and execution risks. ·       Effective cross-functional collaboration, with documented resolution of material review comments. ·       Measurable contribution to improved consistency, cycle time, or audit readiness. · Bachelor’s degree in a scientific, clinical, engineering, or related field, or an equivalent combination of education and directly relevant experience. · Preferred: Advanced degree in vision science, ophthalmology, optometry, clinical research, or a related discipline. · Minimum of 5 years of relevant experience in ophthalmic clinical research, clinical development, clinical evaluation, post-market clinical evidence generation, or a related medical device function. · Preferred: Experience supporting EU MDR clinical documentation or regulatory reviews. · Preferred: Ophthalmic clinical practice, device, or instrumentation experience. · Strong knowledge of ophthalmic instrumentation, including clinical use, device performance, safety, and state of the art.