Senior Compliance Manager – Quality & Regulatory Affairs / QMB ISO 13485 (m/f/d)

<br><strong>Intro</strong><p><p style="line-height:1.295;margin-top:0pt;margin-bottom:8pt;"><span style="font-size:11pt;font-family:Calibri, sans-serif;color:#000000;background-color:transparent;font-weight:400;font-style:normal;text-decoration:none;">Back problems are the most common reason for inability to work in Germany.</span></p><p style="line-height:1.295;margin-top:0pt;margin-bottom:8pt;"><span style="font-size:11pt;font-family:Calibri, sans-serif;color:#000000;background-color:transparent;font-weight:400;font-style:normal;text-decoration:none;">Vivira has the solution: digital exercise therapy via app – always available, simple, effective, and reimbursed by health insurance. Behind every application permanently listed in the DiGA directory stands a robust quality management system. That is exactly why we are looking for you: As Senior Compliance Manager, you will take on the role of Quality Management Representative (QMB) according to ISO 13485 and keep our medical devices MDR-compliant – from the next audit to the inclusion of further products in the DiGA directory.</span></p></p><br><strong>Your responsibilities include</strong><p><p style="line-height:1.295;margin-top:0pt;margin-bottom:8pt;"><span style="font-size:11pt;font-family:Calibri, sans-serif;color:#000000;background-color:transparent;font-weight:400;font-style:normal;text-decoration:none;">As Senior Compliance Manager (m/f/d), you will be responsible for our quality management system and take on the role of Quality Management Representative according to ISO 13485. You report directly to our Team Lead Compliance and work closely with Engineering and Product.</span></p><ul style="margin-top:0;margin-bottom:0;"><li style="list-style-type:disc;font-size:11pt;font-family:Calibri, sans-serif;color:#000000;background-color:transparent;font-weight:400;font-style:normal;text-decoration:none;"><p style="line-height:1.29504;margin-top:0pt;margin-bottom:0pt;"><span style="font-size:11pt;font-family:Calibri, sans-serif;color:#000000;background-color:transparent;font-weight:700;font-style:normal;text-decoration:none;">QMS &amp; Regulatory Affairs:</span><span style="font-size:11pt;font-family:Calibri, sans-serif;color:#000000;background-color:transparent;font-weight:400;font-style:normal;text-decoration:none;"> You monitor compliance with DiGAV, MDR, ISO 13485, and ISO 27001, contribute to our BSI certification topics, and develop processes, SOPs, and Work Instructions pragmatically and based on risk.</span></p></li><li style="list-style-type:disc;font-size:11pt;font-family:Calibri, sans-serif;color:#000000;background-color:transparent;font-weight:400;font-style:normal;text-decoration:none;"><p style="line-height:1.29504;margin-top:0pt;margin-bottom:0pt;"><span style="font-size:11pt;font-family:Calibri, sans-serif;color:#000000;background-color:transparent;font-weight:700;font-style:normal;text-decoration:none;">Technical Documentation:</span><span style="font-size:11pt;font-family:Calibri, sans-serif;color:#000000;background-color:transparent;font-weight:400;font-style:normal;text-decoration:none;"> You create and maintain the Technical Documentation according to MDR (DHF/DMR) for our three medical devices – one app listed in the DiGA directory and two CE-marked products in DiGA studies.</span></p></li><li style="list-style-type:disc;font-size:11pt;font-family:Calibri, sans-serif;color:#000000;background-color:transparent;font-weight:400;font-style:normal;text-decoration:none;"><p style="line-height:1.29504;margin-top:0pt;margin-bottom:0pt;"><span style="