Job Summary The Regulatory Affairs Associate is required to work on a wide variety of regulatory tasks in maintenance of technical documentation, CE marking new devices and maintaining technical files to meet Australian, Canadian and US FDA requirements. These include routine updates in relation to change control, introduction of new devices, support activities in CE marking new devices and file remediation to meet global regulatory requirements. Essential Duties and Responsibilities Writing and updating technical files to meet applicable regulatory requirements, to included Essential Requirements, General Safety and Performance Requirements, Device classification, compiling technical documentation, identification of standar
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