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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. As part of our Compliance team, the QARO ensures that our solutions, processes, and documentation meet all applicable quality and regulatory requirements.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.Review and confirm that manufactured software versions meet conformity requirements before market release.Document Control, Traceability & Complaint Handling:Manage traceability, storage, and controlled handling of quality documents and complaints.Regulatory Monitoring & Documentation: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.Proficiency in Quality Assurance principles, ISO 13485:2016 requirements, and the practical maintenance of a QMS.Practical understanding of software product development workflows; experience with biomedical or health‑related software is an advantage.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.~ Advanced degree in Life Sciences, Engineering, Business, or related field (Master or PhD).
