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The Regulatory Affairs Specialist provides global pre- and post-market support for coronary and renal denervation medical devices; is responsible for activities that lead to and maintain regulatory approval/clearance of these devices; and assesses the global regulatory implications of changes to these devices. The Regulatory Affairs Specialist is responsible for developing regulatory strategies, preparing U.S. and international submissions and obtaining and maintaining approval for class III and/or class IIb products. Additionally, the Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes.