Regulatory Affairs Specialist

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    "description_html": "<p>Job Title: Regulatory Affairs Specialist</p><p>Department: Regulatory</p><p>Reports To: Director of Regulatory Affairs</p><p>FLSA Status: Exempt</p><p>Supervise the work of others: No</p><p><br></p><p>Position Summary:</p><p>This position is responsible for preparing submissions to various regulatory agencies - most notably those pertaining to FDA 510(k) premarket notifications. Additionally the position will help maintain and improve upon engineering document control. Candidate must possess the ability to work well in a team environment and demonstrate great attention to detail.</p><p>Duties and Responsibilities:</p><p>This list is not comprehensive but meant to represent the most common or important duties of the position. Other duties may be assigned.</p><ul><li>Assist with the preparation and submission of regulatory filings, including FDA 510(k) premarket notifications and product listings.</li><li>Create and/or modify regulatory procedures to remain in compliance with FDA, ISO, European, Canadian, and other standards.</li><li>Work with the international department on various regulatory filings for product registration in different countries.</li><li>Provides regulatory support for other projects as required.</li><li>Updating appropriate personnel on new and revised processes and procedures.</li><li>Process, execute, organize and archive various internal documentation related to Engineering and/or Quality Systems.</li><li>Preparing change order documentation and routing it for final approval.</li></ul><p><br></p><p><br></p>",
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