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 RoleAs 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 (Lugo)
🏢 Randstad España
📍 Lugo