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The Director of Regulatory Affairs and Compliance reports to company’s General Counsel and works closely with QA, R&D, Sales, and Marketing. Handle HIPAA, HITECH and FCPA compliance, conduct internal investigations, handle other compliance issues related to the sales and promotion of diagnostic tests or other products of the company to ensure compliance with applicable state, federal and international laws. Manage the operational aspects of regulatory submissions by maintaining timelines, organizing submission content and coordinating the internal and external authoring and review of components.

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Published at 25-07-2014
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