Principal, Clinical Research (Clinical Project Lead – PMCF and Lifecycle Management, Instrumentation)
Core
Lead post-market clinical follow-up (PMCF) and clinical lifecycle management for ophthalmic instrumentation, ensuring compliance with EU MDR and generating real-world evidence.
Role type
Principal, Clinical Project Lead (PMCF and Lifecycle Management)
Builds
PMCF protocols, reports, clinical evaluation documentation, and periodic safety update reports (PSUR) for ophthalmic devices.
Domain
Medical Devices / Ophthalmic Instrumentation / Regulatory Compliance
Required skills
PMCF planning and execution, clinical evaluation review, EU MDR compliance, risk management, benefit-risk assessment, regulatory audit readiness, cross-functional collaboration, evidence gap analysis, scientific judgment, documentation management
Preferred skills
Advanced degree in vision science/ophthalmology/optometry, EU MDR clinical documentation experience, ophthalmic clinical practice or device experience
Technologies
Microsoft Office, literature databases, reference management tools, document management systems, clinical evidence platforms
Responsibilities
Plan and execute PMCF activities including registries and real-world evidence initiatives; Interpret PMCF findings to update PMS and PSUR outputs; Conduct clinical review of clinical evaluation documentation; Assess clinical impact of product changes and safety signals; Contribute to process improvements and knowledge-sharing practices
Seniority
Principal, hands-on IC with strategic oversight