1 jobs found in Mahwah

Work Flexibility: Remote Join Stryker’s Joint Replacement Clinical Affairs team as a Staff Clinical Evaluation Specialist , leading the development and maintenance of clinical evaluation documentation to support brining medical device to market and throughout the product lifecycle. This role combines scientific writing, clinical evidence assessment, regulatory strategy, and project management to support regulatory submissions across multiple global markets. What you will do Lead the preparation and periodic updates of Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), Summary of Safety and Clinical Performance documents (SSCPs), Post-Market Clinical Follow-up Plans (PMCFPs), and Post-Market Clinical Follow-up Reports (PMCFRs) to support regulatory submissions and ongoing compliance. Design compliant, sustainable literature search strategies and conduct systematic literature reviews to identify, evaluate, and summarize published clinical evidence...