Regulatory Specialist

Description:  The successful candidate will implement and manage regulatory activities related to the approval of new in vitro diagnostics (IVDs) and medical devices into the worldwide market. Participate on product development teams responsible for providing guidance on regulatory issues and procedural recommendations for standard operating procedures and protocols. Assist in the evaluation of change control documents for impact on submissions and filing requirements. May interact with regulatory agencies with facilities inspections, licensures and permits. The Specialist ensures regulatory compliance with QSR, ISO, CMDR, IVDD and other worldwide regulatory requirements as appropriate through customer complaints, internal audits and training systems. Helps support clinical trials through coordination of activities, monitoring of sites, and maintenance of data.