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Vivira Health Lab

6 hours ago

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

Remote · Berlin Berlin

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You will manage the quality management system for medical devices and ensure compliance with regulatory standards. This role involves collaboration with various departments to maintain high-quality standards and prepare for audits.

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Job description

You will manage the quality management system for medical devices and ensure compliance with regulatory standards. This role involves collaboration with various departments to maintain high-quality standards and prepare for audits.

Details

  • Berlin, hybrid work with 1–2 days in the office
  • 3+ years of experience in the medical device field
  • Very good German (C1) and English skills

The work

  • Monitor compliance with DiGAV, MDR, ISO 13485, and ISO 27001
  • Create and maintain Technical Documentation for medical devices
  • Prepare and follow up on external audits and conduct internal audits
  • Review and approve release documentation and manage post-market surveillance