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Director of Regulatory Affairs - Early Development Programs for Drugs, Biologics, and Medical Device
RTI International
Durham, North Carolina
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Duke University Health System
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Natividad
Salinas, California
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Alexandria, Virginia
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Regulatory Affairs / Quality Assurance Manager
At EPI, we believe everyone should live life to the fullest, so we create technology that is revolutionizing the way healthcare professionals around the world effectively treat anxiety, insomnia, depression and pain. We are seeking an experienced, street-smart Regulatory Affairs and Quality Assurance Manager to lead the RA/QA functions of EPI. This leader will develop, submit, maintain, and monitor standard operating procedures, policies, practices, and reports to assure compliance with all FDA and international medical device regulatory requirements and applicable standards. Primary Responsibilities: Prepares and evaluates regulatory documents and company specific SOP's, product manuals, Instructions for Use (IFUs), process flows and work in
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