Vivira Health Lab

Compliance

• Own and manage Vivira’s quality management system
• Serve as Quality Management Representative (QMB) under ISO 13485
• Report directly to the Team Lead, Compliance, and collaborate closely with Engineering and Product
• Monitor compliance with DiGAV, MDR, ISO 13485, and ISO 27001
• Contribute to BSI certification activities
• Develop and improve processes, SOPs, and work instructions in a pragmatic, risk-based manner
• Create and maintain MDR technical documentation (DHF/DMR) for three medical devices
• Prepare for and follow up on external audits with the certification body
• Plan and conduct internal audits
• Prepare for the ISO 13485 recertification audit in February 2027
• Review and approve release documentation
• Manage post-market surveillance for Vivira products
• Assess and monitor software suppliers such as Atlassian, HubSpot, and Google based on their criticality
• Evaluate regulatory changes monthly and derive concrete actions
• Act as the primary contact for regulatory questions across departments
• Train colleagues and proactively obtain required contributions
• Potentially take on the PRRC function, depending on qualifications and agreed responsibilities

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Vivira Health Lab

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Senior Compliance Manager – Quality & Regulatory Affairs, QMS Representative (QMB), ISO 13485