Quality Assurance

Company DescriptionThe Quality Assurance & Regulatory Officer (QARO) plays a hands-on role within ELEM’s Quality and Regulatory Affairs.ELEM is a cutting‑edge in silico startup developing virtual human digital twin technology to transform the future of healthcare. To learn more, visit http://elem.bio.As part of our Compliance team, the QARO ensures that our solutions, processes, and documentation meet all applicable quality and regulatory requirements. Role Description1. Design, Development & Technical Documentation: Actively participate in design and development activities to ensure ELEM Solutions complies with applicable standards.Contribute directly to the creation, completion, and maintenance of technical documentation.2. Quality Control, Non‑Conformities & Continuous Compliance: Handle non‑conformities and deviations end‑to‑end, including documentation, investigation, and root cause analysis.Define, implement, and routinely monitor quality controls throughout the product lifecycle.Conduct activities to ensure ongoing compliance with ISO 13485 and IVDR.Review and confirm that manufactured software versions meet conformity requirements before market release.3. Document Control, Traceability & Complaint Handling: Manage traceability, storage, and controlled handling of quality documents and complaints.4. Regulatory Monitoring & Documentation: Monitor changes to regulatory and normative requirements and communicate relevant updates to internal teams.Prepare, compile, and submit regulatory documentation to relevant authorities and stakeholders.Build and maintain working relationships with regulatory stakeholders while responding directly to inquiries from notified bodies, competent authorities, and other relevant parties.5. Product Release & Market Readiness: Perform hands‑on product release activities and verify compliance with ISO 13485 and EU IVDR requirements.6. Audits, Inspections & QMS Maintenance:Prepare, coordinate, and support QMS audits and inspections, serving as the primary point of contact throughout the process.Maintain and update the post‑market surveillance and vigilance system, ensuring timely documentation and follow‑up.7. Reporting & Performance Monitoring:Provide clear reporting on QMS performance, compliance status, and opportunities for improvement.Training, Culture & Cross‑Functional Support: Develop and deliver practical training to ensure staff understand quality and regulatory requirements.Support cross‑functional teams in fostering a strong culture of quality, compliance, and continuous improvement.QualificationsTechnical Requirements and Skills:Proficiency in Quality Assurance principles, ISO 13485:2016 requirements, and the practical maintenance of a QMS.Applied knowledge of IVDR/MDR and relevant regulatory guidelines (EMA, FDA, and others), including hands-on experience with regulatory filings and product registration processes.Practical understanding of software product development workflows; experience with biomedical or health‑related software is an advantage.Education and Experience Requirements:University degree in a life science or a related discipline such as engineering, pharmacy, or another relevant scientific field.Additional training or certification in quality assurance and/or regulatory affairs.2+ years of industrial experience in quality assurance, process management, regulatory affairs, or QMS activities related to medical devices.Fluency in English, both written and spoken.Strong proficiency with Microsoft Office and related productivity tools.Ability to use AI tools effectively.Desirable qualifications for the position:Advanced degree in Life Sciences, Engineering, Business, or related field (Master or PhD).