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

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