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. · Knowledge of EU MDR clinical evidence requirements, ISO 14155, ISO 14971, applicable MDCG guidance, and Notified Body expectations. · Demonstrated ability to lead and execute PMCF activities and conduct clinical review of clinical evaluation documentation. · Strong clinical and scientific judgment to interpret clinical and post-market data, identify evidence gaps, and make sound recommendations. · Proven ability to influence and collaborate across global, cross-functional teams, including Regulatory Affairs, Quality, Medical Safety, Risk Management, · Research and Development, and Clinical Operations. · Ability to work independently, anticipate risks, and drive resolution of complex clinical and regulatory issues. · Proficiency with Microsoft Office, literature databases, reference management tools, document management systems, and clinical evidence platforms. Work hours: 1 PM to 10 PM IST ATTENTION: Current Alcon Employee/Contingent Worker If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason. At Alcon, we are committed to helping people see better. We believe patients should have access to quality eye care regardless of their economic circumstances; however, barriers to good eye health exist for patients in both developed and emerging markets. Alcon develops and manufactures innovative devices to serve the full life cycle of eye care needs. Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction. Its consumer products include the well-known Opti-Free line of contact lens solutions and related products. Alcon, which was founded in 1945, sells its products in 180 countries worldwide. If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker

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

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