Olympus Corporation of the Americas

Manager

• Creation, update and management of Clinical Evaluation Reports (CER), Clinical evaluation plans (CEP), Post-Market Clinical Follow Up Plans (PMCF Plan), Post-Market Clinical Follow Up Reports (PMCF reports), and SSCP (Summary of safety and clinical performance).
• Coordination and review of the CEP, CER, PMCF plan, PMCF report, and SSCP documents as generated by external supplier(s) or Clinical Evaluation Report Writers.
• Systematic analysis of clinical evidence related to Olympus products or diagnostic / therapeutic procedures by literature research in relevant data bases (e.g. Pubmed, Embase, Cochrane).
• Close collaboration with Product Management, Risk Management, R&D and Regulatory Affairs to provide input on deliverables, clinical research and literature evidence and support product development process needs.
• Planning and initiation of Post-market Clinical Follow-up activities together with Product or Marketing Management and clinical affairs.
• Prepare and support audits at OSTA side.
• Report directly to Regional Lead CER.
• Other duties as assigned.

Clinical Evaluation Report Manager