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

Overview

Principal role leading post-market clinical follow-up (PMCF) and clinical lifecycle management activities for ophthalmic instrumentation, including clinical review of clinical evaluation documentation to keep evidence audit-ready.

What you'll do

• Plan and execute PMCF activities, including registries, surveys, retrospective analyses, and real-world evidence initiatives.
• Develop PMCF protocols and reports aligned with Regulation (EU) 2017/745 (EU MDR), applicable MDCG guidance, and internal procedures.
• Interpret PMCF findings against device performance, safety trends, state of the art, risk management, and benefit-risk conclusions.
• Integrate PMCF findings into post-market surveillance (PMS) and periodic safety update report (PSUR) outputs.
• 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.
• Assess the clinical impact of product changes, safety signals, and clinical claims to inform benefit-risk assessments and product change assessments.
• Respond to regulatory, audit, and Notified Body questions as needed.
• Contribute to process improvements, templates, and knowledge-sharing practices that improve quality, efficiency, and audit readiness.

What you'll need

• Bachelor's degree in a scientific, clinical, engineering, or related field, or an equivalent combination of education and directly relevant experience.
• 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.
• 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.

Nice to have

• Advanced degree in vision science, ophthalmology, optometry, clinical research, or a related discipline.
• Experience supporting EU MDR clinical documentation or regulatory reviews.
• Ophthalmic clinical practice, device, or instrumentation experience.

Details

• Location: Bangalore, India.
• Work hours: 1 PM to 10 PM IST.