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    "requisitionDescription": "<div><p style='margin:0in;font-size:16px;font-family:\"Times\",serif;margin-bottom:6.0pt;' data-pasted=\"true\"><strong><u><span style='font-size:15px;font-family:\"Times New Roman\",serif;'>GENERAL SUMMARY</span></u></strong></p><p style='margin:0in;font-size:16px;font-family:\"Times\",serif;text-align:justify;'><span style='font-size:15px;font-family:\"Times New Roman\",serif;'>Sets strategic direction and ensures success of the Complaint Handling, MDR and post market reporting programs. Makes critical decisions for the Complaint Handling Unit (CHU). Primary interface to other department heads and upper management for complaint related topics and trending. Ensures complaint management procedures are optimized and that the vigilance team responds to and resolves complaints within a timely fashion while conforming to appropriate standards and procedures.&nbsp;</span></p><p style='margin:0in;font-size:16px;font-family:\"Times\",serif;text-align:justify;'><br></p><p style='margin:0in;font-size:16px;font-family:\"Times\",serif;margin-bottom:6.0pt;text-align:justify;'><strong><u><span style='font-size:15px;font-family:\"Times New Roman\",serif;'>ESSENTIAL JOB FUNCTIONS</span></u></strong></p><ul style=\"margin-bottom:0in;margin-top:0in;\" type=\"disc\"><li style=\"margin:0in;font-size:16px;font-family: initial;\"><span style='font-size:15px;font-family:\"Times New Roman\",serif;'>Execute complaint vigilance in conformance to current standards and procedures, using applicable system application tools in accordance with 21CFR820, 21CFR803, ISO 13485, and other regulations as required.&nbsp;</span></li><li style=\"margin:0in;font-size:16px;font-family: initial;\"><span style='font-size:15px;font-family:\"Times New Roman\",serif;'>Oversee the initial assessment of complaints and assess risk and severity in accordance with product risk management files.</span></li><li style=\"margin:0in;font-size:16px;font-family: initial;\"><span style='font-size:15px;font-family:\"Times New Roman\",serif;'>Oversee the receipt, evaluation, investigation, and closure of complaints, including device malfunctions.&nbsp;</span></li><li style=\"margin:0in;font-size:16px;font-family: initial;\"><span style='font-size:15px;font-family:\"Times New Roman\",serif;'>Work with product/manufacturing/research &amp; development/quality/medical affairs teams to ensure timely, accurate and complete investigations of product complaints and timely closures.&nbsp;</span></li><li style=\"margin:0in;font-size:16px;font-family: initial;\"><span style='font-size:15px;font-family:\"Times New Roman\",serif;'>Prepare reports with analysis of complaint trends.&nbsp;</span></li><li style=\"margin:0in;font-size:16px;font-family: initial;\"><span style='font-size:15px;font-family:\"Times New Roman\",serif;'>Oversee the assessment of complaints for MDR reportability to FDA.&nbsp;</span></li><li style=\"margin:0in;font-size:16px;font-family: initial;\"><span style='font-size:15px;font-family:\"Times New Roman\",serif;'>Ensure initial and follow-up reports are submitted to Regulatory Agencies within required timelines.&nbsp;</span></li><li style=\"margin:0in;font-size:16px;font-family: initial;\"><span style='font-size:15px;font-family:\"Times New Roman\",serif;'>Ensure complaints are classified correctly and that all supporting data are adequately documented and attached to the complaint file.&nbsp;</span></li><li style=\"margin:0in;font-size:16px;font-family: initial;\"><span style='font-size:15px;font-family:\"Times New Roman\",serif;'>Ensure procedures meet current and evolving requirements.&nbsp;</span></li><li style=\"margin:0in;font-size:16px;font-family: initial;\"><span style='font-size:15px;font-family:\"Times New Roman\",serif;'>Track and report metrics on process timeliness and effectiveness.&nbsp;</span></li><li style=\"margin:0in;font-size:16px;font-family: initial;\"><span style='font-size:15px;font-family:\"Times New Roman\",serif;'>Represent the complaint handling unit in FDA inspections.&nbsp;</span></li></ul><p style='margin:0in;font-size:16px;font-family:\"Times\",serif;'><br></p><h1 style='margin:0in;text-align:left;font-size:16px;font-family:\"Times\",serif;text-decoration:underline;margin-bottom:6.0pt;'><span style='font-size:15px;font-family:\"Times New Roman\",serif;'>OTHER DUTIES AND RESPONSIBILITIES</span></h1><div align=\"center\" style='margin:0in;font-size:16px;font-family:\"Times\",serif;'><table border=\"0\" cellspacing=\"1\" cellpadding=\"0\" width=\"100%\" style=\"width:100.0%;\"><tbody><tr><td style=\"padding:.75pt .75pt .75pt .75pt;height:2.9pt;\"><ul type=\"disc\" style=\"margin-bottom:0in;\"><li style=\"margin:0in;font-size:16px;font-family: initial;\"><span style='font-size:15px;font-family:\"Times New Roman\",serif;'>Conduct annual complaint training for all employees including field sales on the requirements to report complaints in a timely manner.&nbsp;</span></li></ul></td></tr><tr><td style=\"padding:.75pt .75pt .75pt .75pt;\"><p style='margin:0in;font-size:16px;font-family:\"Times\",serif;'><br></p></td></tr></tbody></table></div><h2 style='margin:0in;font-size:16px;font-family:\"Times New Roman\",serif;text-decoration:underline;margin-bottom:6.0pt;'><span style=\"font-size:15px;\">PREPARATION, KNOWLEDGE, SKILLS &amp; ABILITIES</span></h2><ul style=\"margin-bottom:0in;margin-top:0in;\" type=\"disc\"><li style=\"margin:0in;font-size:16px;font-family: initial;margin-bottom:6.0pt;\"><span style='font-size:15px;font-family:\"Times New Roman\",serif;'>Bachelor&rsquo;s degree in science or engineering with 10+ years of experience or Master&rsquo;s degree with 7+ years of experience in medical device. Extensive experience and deep working knowledge of complaint vigilance and MDR reporting.&nbsp;</span></li><li style=\"margin:0in;font-size:16px;font-family: initial;margin-bottom:6.0pt;\"><span style='font-size:15px;font-family:\"Times New Roman\",serif;'>Experienced in regulatory inspections and skilled in interacting with government officials.&nbsp;</span></li><li style=\"margin:0in;font-size:16px;font-family: initial;margin-bottom:6.0pt;\"><span style='font-size:15px;font-family:\"Times New Roman\",serif;'>The Complaints Vigilance Director is responsible for managing the Vigilance Team. Responsible for team goal setting and performance assessments, as well as day-to-day people management.&nbsp;</span></li></ul></div>\n",
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