The Quality & Regulatory (Q&R) manager leads all the Q&R related activities in Xyall. The manager will be responsible that all products of Xyall adheres to the legal requirements of countries, where Xyall is active. Next, the Q&R manager will maintain the Quality Management System of Xyall; Xyall is ISO 13485 certified. Also the records to support the evidence, that Xyall actively uses and adheres to its QMS, need to be controlled by the Q&R manager. Products and organisation need to adhere to Good Manufacturing Practices. The manager makes sure that all employees of Xyall are properly trained concerning the QMS and other relevant Q&R related matters, and will keep contact with the suppliers of Xyall, notified bodies and others external parties concerning Q&R matters.

Key Areas of Responsibility

  • Manages all regulatory affairs, that are relevant for Xyall.
  • Developing, Implementing and Maintaining the Quality Management System per relevant standards and regulations (ISO 13485 and FDA 21 CFR 820)
  • Manages and maintains documentation related to quality processes, procedures, and product records
  • Prepares all relevant audits and will do the follow-up of the actions (ISO 13485, Supplier audits, internal audits, etc) 
  • Ensures that all documentation, including Design History Files, Device Master Records, Device History Records, is complete, accurate, up-to-date, and accessible to relevant stakeholders
  • Makes sure that all major suppliers and partners adhere to the Q&R requirements of Xyall
  • Development and maintenance of technical files for regulatory compliance
  • Obtain and maintain product registration (EU and US)
  • Manages all contacts with Notifies bodies

Placement in the Organization

Member of the Management Team. Manager of the Q&R activities. Reports to the COO of Xyall.


  • Proven experience in both areas of Quality Assurance and Regulatory Affairs
  • Experience with obtaining regulatory compliance in the US and EU market
  • Experience in Healthcare/Medical Devices
  • Has a strong affinity with technology and experience in working with R&D and M&S
  • Result driven; “get things done” mentality
  • Good analytical and communication skills
  • Likes to work for a start-up company; flexibility in such an environment is required
  • At least three days per week presence in the office in Eindhoven
  • Education level: at least BSc
  • Affinity with High-Tech


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