About this role
<div align="center"> <table style="width:7.25in;border-collapse:collapse;border-style:hidden" border="0" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="width:7.25in" colspan="2" valign="top"> <p><strong>Location: </strong>Onsite</p> <p><strong>Status Type: </strong>Full Time</p> <p> </p> <p><strong>QUALIFICATIONS</strong></p> <p> </p> <p><strong><u>Required:</u></strong></p> <ul> <li>Bachelor’s in biology, chemistry, engineering, or related science field</li> </ul> <p> </p> <p><strong><u>Skills & Competencies:</u></strong></p> <ul> <li>Strong interpersonal skills</li> <li>Technical/scientific writing experience</li> <li>Proficiency in PowerPoint and Microsoft Office</li> <li>Strong initiative and eagerness to learn</li> </ul> <p> </p> <p><strong><u>Physical Requirements:</u></strong></p> <ul> <li>Must be able to remain in a stationary position for extended periods of time</li> <li>Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.</li> <li>Position requires being physically present on the premises during regular company hours or as approved by management</li> </ul> <p> </p> <p><strong>RESPONSIBILITIES:</strong></p> <ul> <li>Support cross-functional team deliverables and regulatory submissions</li> <li>Assist Regulatory Lead in executing deliverables</li> <li>Perform literature-based research</li> <li>Write technical summaries</li> <li>Assist in preparation of master files, technical files, and other submissions (US and global)</li> <li>Support preparation of finished product artwork and labels</li> <li>Develop knowledge of ISO 13485, 21 CFR 820, 21 CFR Part 4 requirements and domestic/international regulatory framework</li> <li>Support post-market surveillance obligations per applicable US and global requirements (including MDR)</li> <li>Ensure finished product artwork and labels are clear, comprehensible, and user-friendly</li> <li>Assist in preparation of documentation for investigational clinical studies (IND, IDE) in US and globally</li> <li>Support cross-functional team activities as directed</li> </ul> </td> </tr> </tbody> </table> </div> <p> </p>