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 robust risk management practice.
Assume the role of a PRRC.
Lead regulatory processes including product registration and Post Market Surveillance activities.
Own and independently manage the end-to-end submission of IVD device(s) for IVD certification, including technical documentation, conformity assessment, and Notified Body liaison.

What We Are Looking For:
Education: Bachelor's or Master's degree in a relevant scientific, biological, or engineering field.
Experience: 5+ years of quality management experience within the Medical Device or In Vitro Diagnostics (IVD) sectors, with a proven track record of working independently at a senior level.

Regulatory & Standards:
Hands-on experience leading ISO 13485 audits from preparation to closure.
Hands-on experience managing ISO 27001 audits from preparation to closure.
Proven track record leading IVD certification submissions in Europe (from technical file compilation through to approval).
Solid command of relevant EU regulations and quality standards (including IVDR and GDPR).

Technical & Domain Expertise:
Experience within Next Generation Sequencing (NGS) or genetics is highly desirable.
Interest in software development and process automation using digital/software tools.
Soft Skills & Languages:
Excellent problem-solving skills with a root-cause analysis mindset.
Strong cross-functional collaboration and communication skills.
Fluency in English (C1 level minimum), both written and spoken.

📌 Senior QARA (SaMD)-100% Remote (Spain)
🏢 Randstad España
📍 Marzán