Manager, Clinical Affairs and Regulatory Submissions

Summary:

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Supports the Director of Clinical Affairs and the company in the design, initiation, monitoring and close-out of clinical studies for evaluation of the company?s in vitro diagnostic products. Manages preparation of FDA submissions.? Ensures adherence to company SOP?s for conducting device clinical studies and preparing FDA submissions.? Takes responsibility as the project leader of selected clinical studies.

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Supervisory Responsibilities:

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Directly supervises one or more employees in the Department of Clinical Affairs and Regulatory Submissions.? Carries out supervisory responsibilities in accordance with the organization?s policies and applicable laws.

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Other Essential Duties and Responsibilities:

?Coordinates administrative activities related to the design and management of clinical trials of in vitro diagnostic devices.Performs literature retrieval in order to stay abreast of scientific information.Researches scientific evidence and current clinical use of in vitro assays in preparation for clinical protocol development.Prepares clinical trial protocols.Develops clinical site monitoring schedule.Initiates and monitors investigational studies to ensure protocol compliance.Communicates with study investigators regarding all phases of the study.Manages incoming clinical site data, designs/maintains databases, performs statistical analysis.Prepares and submits 510K?s and PMA?s to the FDA for product clearance/approval.Takes responsibility for PMA annual reports.Takes responsibility for review of marketing materials with respect to product claims.Assists in the training of new staff.

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Education/Experience:

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Master?s degree (M.A. or M.S.) is preferred along with 8-10 years of experience in Clinical Affairs and Regulatory Submissions.