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
📍 Ourense