Head of IVD Regulatory Affairs - (Philadelphia, PA)

Group K Diagnostics is seeking a Regulatory Affairs Manager for IVD products to provide executable US FDA regulatory strategies, current understanding of International regulatory strategy, and to deliver regulatory operations and compliance qualifications. Work is generally independent and collaborative to execute activities related to maintaining compliant regulatory status for marketed products including change management, biological deviation reports, annual reporting, labeling review, audit support, develop and update procedures, etc. Tasks And Responsibilities Manages regulatory responsibilities associated with the development, support and manufacturing of GKD products. Manages US regulatory submissions, including 510(k)s and CLIA waivers, as well as EU regulatory submissions..