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The Senior Director, Regulatory Affairs is responsible for leading the development and execution of the company’s Regulatory strategies. Success will be demonstrated through a strong knowledge of FDA and international guidance and regulations. As a Senior Director, this role acts as a liaison with business leadership to ensure that new market regulatory strategies are defined and implemented. The role acts as a subject matter expert for regulatory processes for Tandem products requiring FDA and OUS agency approvals by ensuring that all necessary applications and submissions are filed accurately and timely. As an RA leader, this role drives the continuous assessment and improvement of key business and regulatory processes to ensure compliance with regulations set forth by the USFDA, Interna...