Our client is at the forefront of personalized medicine, developing cutting-edge Next-Generation Sequencing (NGS) software and AI-native diagnostic platforms designed to democratize advanced cancer care globally.

This position is 100% remote from anywhere in Spain.

The Role

As a Senior QARA Specialist, you will bridge the gap between strict regulatory compliance and fast-paced software development. You will play a key role in maintaining their Quality Management System and driving regulatory pathways for cutting-edge Software as a Medical Device and In Vitro Diagnostics.

Key Responsibilities:
- Develop and maintain a QMS that aligns with industry requirements and best practices.
- Develop documentation processing and creation automation within the relevant compliance frameworks.
- Stay updated with relevant regulations and standards in the industry such as IVDR, ISO 13485, ISO 27001 and GDPR, ensuring process compliance.
- Support and manage timely responses to nonconformities, deviations, and other issues including implementing corrective and preventive actions.




- Oversee document control processes to ensure the accuracy, completeness, and accessibility of all quality-related documentation.
- Collaborate with teams to develop and deliver quality-related training programs, fostering a culture of quality awareness and continuous improvement.
- Work closely with suppliers to establish and maintain quality agreements, monitor supplier performance, and ensure the quality of products and services.
- Work closely with R&D; on device roadmaps and overall D&D; process including Design & Development File creation and maintenance.
- Work closely with Operations on product configuration and documentation, including product identification and traceability (UDI).
- Lead initiatives to identify and implement process improvements across all aspects of internal operations.
- Manage internal and external audits independently, including ISO 13485 and ISO 27001 audits.
- Manage a ro

📌 Senior QARA (España)
🏢 Randstad España
📍 España