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Medical Device Compliance Specialist

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Liège, Wallonie, Belgique Guided Solutions Temps plein
About the Role

We are seeking a Medical Device Compliance Specialist to join our team at Guided Solutions. In this role, you will be responsible for ensuring the quality and safety of our Class 3 medical devices.

You will have a deep understanding of regulatory requirements, including FDA Quality System Regulations (QSR), ISO 13485 standards, and other global regulations and standards.

  • Responsibilities:
  • Evaluate and maintain compliance with regulatory requirements, including FDA QSR, ISO 13485, and other applicable global regulations and standards.
  • Develop, implement, and maintain a quality management system (QMS) that meets regulatory requirements.
  • Conduct audits and assessments to ensure compliance with regulatory requirements.
  • Maintain accurate and detailed documentation, including device master records, design history files, and quality records.