The Senior Clinical Affairs Specialist is responsible for developing clinical evidence strategies and authoring clinical evidence documents for Cantel businesses. This position translates data from a variety of sourcesin creating medical device clinical evidence, which is used in support of regulatory applications andbusiness objectives. The Senior Clinical Affairs Specialist helps support new product developmentactivities as well as maintaining currently marketed devices. #CB

• Authors Clinical Evaluation Plans and Reports, Clinical Literature Search Reports, Post Market Clinical Follow-up Plans and Reports.
• Evaluates and generates clinical evidence from a variety of sources; literature, post-market surveillance, instructions for use, and risk documentation.
• Collaborates with cross-functional colleagues in planning and supporting clinical evidence related projects and processes.
• Identifies appropriate sources of relevant data, interprets, evaluates and incorporates into clinical evaluation documents.
• Reviews risk management files, instructions for use, clinical evidence documents, training materials, regulatory submissions, and promotional collateral to ensure alignment of risk information.
• Works with cross-functional peers to resolve technical issues and questions from regulatory agencies.
• Updates and remediates, as necessary, historical clinical documentation to meet current standards.
• Participates in audit preparation activities, audit room support, and post-audit deliverables.
• Develops and designs clinical trial designs to support post-market, and where applicable, pre-market requirements.
• Maintains proficiency in government regulations and guidances.
• Develops and maintains procedures to ensure compliance and support business goals.