RA/QA Specialist

<p><strong>About us </strong></p><p>Idoven is a European healthtech company using artificial intelligence to advance the early diagnosis of cardiovascular diseases, the leading cause of death worldwide.</p><p>Our CE-marked AI platform, Willem, analyzes electrocardiograms (ECGs) from any device, helping doctors detect heart conditions faster, more accurately and at scale.</p><p>Backed by the European Innovation Council, Horizon 2020, and top-tier investors, we’re building technology with the potential to save millions of lives.</p><p>We collaborate with leaders like AstraZeneca, Abbott and EIT Health, and our work has been recognized by the European Seal of Excellence, the U.S. National Academy of Medicine, CB insights' Digital Health Lists, and South Summit as Most Disruptive Startup.</p><p>Global icons Iker Casillas and Pau Gasol support our mission as brand ambassadors, helping raise awareness around heart health. We have created the first mobile app that allows people to donate their heartbeats — turning everyday signals into science with the purpose of preventing heart disease.</p><p>If you're looking to build technology with real-world impact at one of Europe’s most promising deep-tech companies, Idoven is the place to do it.</p><p></p><p><strong>About the Role</strong></p><p>The <strong>Regulatory Affairs and Quality Assurance Specialist</strong> is primarily focused on the execution and technical documentation required to maintain the effectiveness of the <strong>Quality Management System (QMS) </strong>and <strong>support product lifecycle activities</strong>, <strong>working collaboratively</strong> across functional teams.</p><p></p><ul><li><strong>QMS Execution &amp; Compliance: </strong>Support the maintenance and execution of the Quality Management System (QMS), ensuring compliance is continuously maintained or enhanced.</li><li><strong>Documentation Control: </strong>Prepare and coordinate Quality Records and Technical Documentation (e.g., DHF, DMR, Design Changes) to support regulatory needs and internal quality audits.</li><li><strong>Audit Coordination: </strong>Coordinate the collection and presentation of documentation for internal and external quality audits.</li><li><strong>Cross-Functional Collaboration: </strong>Collaborate closely with Regulatory, R&amp;D, and management to support the execution of quality strategies that ensure products meet specifications and maximize customer value.</li><li><strong>Technical Guidance: </strong>Provide Quality and QMS guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.</li><li><strong>Process Improvement:</strong> Assist in the formulation and implementation of existing Quality policies and procedures, and proactively identify inefficiencies or errors in existing processes.</li><li><strong>Risk Identification:</strong> Proactively identify Quality risks to company's programs and support the development and execution of corrective and risk mitigation plans (e.g., CAPA, Non-conformance).</li><li><strong>Knowledge &amp; Training: </strong>Keep up to date on Quality standards (e.g., ISO 13485, industry best practices) and provide training, interpretation of quality guidelines or issues to personnel, including training others for audit readiness.</li></ul><p></p><p><strong>Requirements</strong></p><p><strong>Required Qualifications:</strong></p><ul><li>Bachelor's degree or experience in a related field (Master's degree a plus)</li><li>Min. 3 years of demonstrated experience in Regulatory Affairs &amp; Quality Assurance/Quality Systems roles preferably within the Medical Device industry.</li><li>Fluency in English is required, Spanish is nice to have.</li><li>Demonstrated experience with Medical Device QMS documentation for the EU MDR and the US FDA (21 CFR).</li><li>Strong analytical and problem-solving skills.</li><li>Excellent verbal and written communication skills.</li><li>Ability to translate complex technical concepts and quality requirements to the intended audience in a clear and understandable way.</li><li>Ability to collaborate and communicate effectively in a flat-hierarchy, fast-paced startup environment while efficiently functioning with a high level of autonomy.</li><li>In-depth attention to detail and accuracy with the ability to prioritize and work on multiple projects in a fast-paced, start-up environment.</li><li>Basic understanding of software development life cycle is a plus.</li></ul><p></p><p><strong>Desired Qualifications: </strong></p><ul><li>Basic understanding of regulatory affairs for medical devices is a plus.</li><li>Familiarity with the regulatory submission process (e.g., FDA 510(k), CE mark documentation) is a plus.</li><li>Experience navigating a regulated industry environment is a plus.</li></ul><p><strong>Benefits</strong></p><p>🚀 Be part of one of the most disruptive startups in HealthTech and AI and make a difference</p><p>🏆 Personal and professi