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Regulatory Affairs Manager
The Regulatory Affairs Manager will be responsible for: . Developing and implementing regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards . Ensuring compliance with global regulations and regulating agencies . Interpret the intent of regulations and policies and provide such information to project teams and management . Instilling and driving a regulatory culture across the organization . Establishing and supporting policies and standards for the measurement of new products . Developing IDE, 510K, and PMA submissions for class II and III medical devices . Conducting submission negotiations with the FDA as needed, including pre-submission identification of requirements and strategy and post...
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