As a QM/RA professional at our Valencia site, you will be a key member of our Germany-based Quality Management & Regulatory Affairs team. You will ensure compliance with international quality standards and regulatory requirements and continuously develop and improve all related processes.

Key Responsibilities

• Implement and maintain a quality management system compliant with ISO 15189, including:

  • Supplier management

  • Event handling

  • Change control

• Act as the on-site lead for internal and external audits by accrediting agencies

• Identify and evaluate local regulatory requirements for clinical diagnostic laboratories

• Support internal stakeholders in implementing QMS and regulatory requirements

• Create and maintain technical documentation for in vitro diagnostic medical devices

• Deputize for the head of department as local PRRC in accordance with §15 IVDR

• Manage communication with local regulatory authorities to maintain licensure as required