Director of Regulatory Affairs

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    "requisitionDescription": "<div>\n    <link href=\"https://static.workforcenow.adp.com/mas/mdf-components/22.3.26/styles/froala_editor.pkgd.min.css\" rel=\"stylesheet\" type=\"text/css\" />\n    <link href=\"https://static.workforcenow.adp.com/mas/mdf-components/22.3.26/styles/froala_style.min.css\" rel=\"stylesheet\" type=\"text/css\" />\n\n    <div class=\"fr-view\">\n      <p id=\"isPasted\"><strong>SUMMARY:&nbsp;</strong>Manage day to day activities for Regulatory Affairs function. &nbsp;Partner with internal departments and external consultants to efficiently deliver accurate, timely, and effective regulatory documents, deliverables and other projects in line with company policies and procedures. &nbsp;&nbsp;Provide regulatory guidance with various ongoing cross-functional projects in order to remain in compliance with all FDA and other U.S. and international regulatory requirements.&nbsp;</p><p><strong>&nbsp;</strong></p><p><strong>ESSENTIAL DUTIES AND RESPONSIBILITIES&nbsp;</strong>include the following. &nbsp; Other duties may be assigned on an individual basis:</p><ul><li>Partner with Senior Management to define and execute on the company&rsquo;s regulatory strategy and priorities</li></ul><ul type=\"disc\"><li>Key contact for FDA and Notified Body submissions and onsite audit management</li><li>Prepare regulatory filings such as 510(k), IDE, &nbsp;Design Dossier, Notified Body submissions and subsequent revisions/supplements and amendments by managing all associated deliverables and timelines</li></ul><ul><li>Represent Regulatory discipline in Project Teams to ensure timelines and resource allocations are factored into deliverables</li><li>Develop global regulatory strategies for various projects</li></ul><ul type=\"disc\"><li>Prepare various presentations to regulatory agency reviewers and/or inspectors as needed</li><li>Review and approve Documents Change Order requests, CAPA&rsquo;s, NCMR&rsquo;s, etc.</li><li>Ensure compliance with FDA and OUS regulations and guidelines as well as relevant company SOPs and protocols</li><li>Manage coordination of international product registrations and licensing documentation</li><li>Partner with Clinical to provide input and prepare critical data for physicians and proposals</li><li>Act as regulatory representative on project teams to ensure timeliness and resource allocations are factored into deliverables</li><li>Develop and manage departmental budgets</li><li>Actively promote and support the Quality Management System, Quality Objectives, and Quality Policy.</li><li>Assure that you and functional subordinates (if applicable) are trained on all applicable procedures and processes according to Good Manufacturing Practices, applicable FDA and Regulatory requirements.&nbsp;</li><li>Actively promote and support the company&rsquo;s Management Review process. &nbsp;</li><li>Inform responsible personnel of concerns involving product quality.</li><li>Perform job functions in a safe and effective manner.</li><li>Other duties as assigned</li></ul><p>&nbsp;</p><p>&nbsp;</p><p>&nbsp;</p><p><strong><u>EDUCATION/EXPERIENCE: &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</u></strong></p><ul><li>Bachelor&rsquo;s degree in a related field and 10+ years&rsquo; experience in healthcare-related industries, including 5 or more years&rsquo; experience in the medical device industry</li><li>Expertise with MDRs, IDEs and 510(k) filings</li><li>An advanced degree is desirable. &nbsp;Medical device product experience a plus. &nbsp;</li><li>Excellent written and oral communication skills; technical writing capabilities are a must</li><li>A proven decision maker, hands-on and action-oriented style must be evident</li><li>Prior management training and experience is desired</li><li>RAC certification a plus</li><li>Proven ability to manage a team of regulatory professionals and prioritize multiple projects independently</li></ul>\n    </div>\n  </div>\n",
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