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Quality/Regulatory Assurance Manager

Posted on Dec 12, 2018 by US Endodontics

Johnson City, TN 37604
Research & Development
4 Dec 2018
Annual Salary
Full-Time
RESPONSIBILITIES * Provide responses to regulatory agencies regarding product information or issues. * Train staff in regulatory policies or procedures. * Coordinate internal discoveries and depositions with quality department. * Establish regulatory priorities or budgets and allocate resources and workloads. * Maintain current knowledge of relevant regulations, including proposed and final rules. * Manage activities such as regulatory agency audits, or product recalls. * Participate in the development or implementation of clinical trial protocols. * Direct the preparation and submission of regulatory agency applications, reports, or correspondence. * Communicate regulatory information to multiple departments and ensure that information is interpreted correctly. * Develop regulatory strategies and implementation plans for the preparation and submission of new products. * Oversee documentation efforts to ensure compliance with domestic and international regulations and standards. * Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products. * Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. * Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met. * Contribute to the development or implementation of business unit strategic and operating plans. * Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations. * Monitor regulatory affairs trends that are related to environmental issues. * Assist with Quality tasks as needed. * Perform other business-related duties as requested Category: Quality Control , Keywords: Quality Control / Quality Assurance Manager

Reference: 598096307