Quality / Regulatory Associate

ABOUT CUREMETRIX - www.CureMetrix.comCureMetrix is a global leader in Artificial Intelligence for medical imaging, committed to advancing technology that improves healthcare and survival rates across the globe. Its mission is to help save lives with early and more accurate detection and support improved clinical and financial outcomes, delivering technology that radiologists, healthcare systems, and patients can rely on with confidence.If you want to be part of innovation that saves lives, take a giant step in your career, and put your hands-on experience to work in a successful start-up environment, we want you to join and grow with our team.ROLE OVERVIEWWe're looking for a detail-oriented Quality/Regulatory Associate to support the execution and ongoing maintenance of our Quality Management System (QMS) and assist with global regulatory submissions. You'll work closely with our Head of Quality and Head of Regulatory Affairs, taking ownership of key operational workflows that keep our quality system running smoothly and our regulatory activities on track. This is an excellent opportunity for someone who enjoys process ownership, thrives in a fast-moving environment, and wants to deepen their expertise in both medical device quality systems and global regulatory submissions.RESPONSIBILITIESQuality system operations: Manage controlled documents and records throughout their full lifecycle — creation, review, approval, revision, and archivalAdminister training assignments and maintain training records within the QMSCollaborate with technical experts to draft and review design documentation, including risk management and V&V materialsSupport CAPA investigations, root cause analysis, and corrective action trackingAssist with post-market surveillance and complaint handling documentationMaintain quality records to ensure ongoing audit readiness and regulatory complianceSupport supplier documentation management and internal/external audit preparationRegulatory operations: Assist with preparation and compilation of global regulatory submissions (e.g., 510(k), technical documentation, international registrations)Maintain regulatory submission trackers, registration records, and supporting documentationManage regulatory project tracking using Monday.com and other planning toolsPerform regulatory research to support market access and submission planningEnsure document traceability, version control, and proper regulatory recordkeepingQUALIFICATIONSBachelor's degree in life sciences, engineering, or a related field2–3 years of experience in a regulated environment (medical device, biotech, life sciences, or healthcare)Hands-on experience within an ISO 13485 quality management systemPrior experience in a fully remote or distributed professional environmentREQUIRED SKILLSStrong analytical, organizational, and documentation skills with exceptional attention to detailProficiency with Microsoft Office (Word, Excel, PowerPoint)Comfortable owning operational tasks and driving them to completion with minimal supervisionPREFERRED SKILLSFamiliarity with FDA 21 CFR Part 820Experience with an eQMS platform (e.g., Qualio)Exposure to medical device regulatory submissions or audit supportWe're a small, mission-driven team working on technology that genuinely helps patients. You'll have real ownership of meaningful work, visibility across both quality and regulatory functions, and the opportunity to grow alongside a company making a difference in women's health and cardiovascular risk detection.