Senior QARA

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.