{"schemaVersion":"jobsearcher.job.v1","id":"adb170dcda61ae66bbbb1df0","url":"https://jobsearcher.com/jobs/adb170dcda61ae66bbbb1df0","canonicalUrl":"https://jobsearcher.com/jobs/adb170dcda61ae66bbbb1df0","title":"Quality / Regulatory Associate","description":"ABOUT CUREMETRIX -www.CureMetrix.com\r\nCureMetrix 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.\r\nIf 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.\r\nROLE OVERVIEW\r\nWe'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.\r\nRESPONSIBILITIES\r\nQuality system operations:\r\nManage controlled documents and records throughout their full lifecycle creation, review, approval, revision, and archival\r\nAdminister training assignments and maintain training records within the QMS\r\nCollaborate with technical experts to draft and review design documentation, including risk management and V&V materials\r\nSupport CAPA investigations, root cause analysis, and corrective action tracking\r\nAssist with post-market surveillance and complaint handling documentation\r\nMaintain quality records to ensure ongoing audit readiness and regulatory compliance\r\nSupport supplier documentation management and internal/external audit preparation\r\nRegulatory operations:\r\nAssist with preparation and compilation of global regulatory submissions (e.g., 510(k), technical documentation, international registrations)\r\nMaintain regulatory submission trackers, registration records, and supporting documentation\r\nManage regulatory project tracking using Monday.com and other planning tools\r\nPerform regulatory research to support market access and submission planning\r\nEnsure document traceability, version control, and proper regulatory recordkeeping\r\nQUALIFICATIONS\r\nBachelor's degree in life sciences, engineering, or a related field\r\n23 years of experience in a regulated environment (medical device, biotech, life sciences, or healthcare)\r\nHands-on experience within an ISO 13485 quality management system\r\nPrior experience in a fully remote or distributed professional environment\r\nREQUIRED SKILLS\r\nStrong analytical, organizational, and documentation skills with exceptional attention to detail\r\nProficiency with Microsoft Office (Word, Excel, PowerPoint)\r\nComfortable owning operational tasks and driving them to completion with minimal supervision\r\nPREFERRED SKILLS\r\nFamiliarity with FDA 21 CFR Part 820\r\nExperience with an eQMS platform (e.g., Qualio)\r\nExposure to medical device regulatory submissions or audit support\r\nWe'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.","company":"Curemetrix","rawCompany":"curemetrix","city":"Poway","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-04-11T01:19:54.450Z","occupations":[{"code":"13-1041.07","title":"Regulatory Affairs Specialists","slug":"regulatory-affairs-specialists"},{"code":"11-9199.01","title":"Regulatory Affairs Managers","slug":"regulatory-affairs-managers"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"industries":[{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality / Regulatory Associate","description":"ABOUT CUREMETRIX -www.CureMetrix.com\r\nCureMetrix 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.\r\nIf 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.\r\nROLE OVERVIEW\r\nWe'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.\r\nRESPONSIBILITIES\r\nQuality system operations:\r\nManage controlled documents and records throughout their full lifecycle creation, review, approval, revision, and archival\r\nAdminister training assignments and maintain training records within the QMS\r\nCollaborate with technical experts to draft and review design documentation, including risk management and V&V materials\r\nSupport CAPA investigations, root cause analysis, and corrective action tracking\r\nAssist with post-market surveillance and complaint handling documentation\r\nMaintain quality records to ensure ongoing audit readiness and regulatory compliance\r\nSupport supplier documentation management and internal/external audit preparation\r\nRegulatory operations:\r\nAssist with preparation and compilation of global regulatory submissions (e.g., 510(k), technical documentation, international registrations)\r\nMaintain regulatory submission trackers, registration records, and supporting documentation\r\nManage regulatory project tracking using Monday.com and other planning tools\r\nPerform regulatory research to support market access and submission planning\r\nEnsure document traceability, version control, and proper regulatory recordkeeping\r\nQUALIFICATIONS\r\nBachelor's degree in life sciences, engineering, or a related field\r\n23 years of experience in a regulated environment (medical device, biotech, life sciences, or healthcare)\r\nHands-on experience within an ISO 13485 quality management system\r\nPrior experience in a fully remote or distributed professional environment\r\nREQUIRED SKILLS\r\nStrong analytical, organizational, and documentation skills with exceptional attention to detail\r\nProficiency with Microsoft Office (Word, Excel, PowerPoint)\r\nComfortable owning operational tasks and driving them to completion with minimal supervision\r\nPREFERRED SKILLS\r\nFamiliarity with FDA 21 CFR Part 820\r\nExperience with an eQMS platform (e.g., Qualio)\r\nExposure to medical device regulatory submissions or audit support\r\nWe'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.","datePosted":"2026-04-11T01:19:54.450Z","dateModified":"2026-04-11T01:19:54.450Z","hiringOrganization":{"@type":"Organization","name":"Curemetrix","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Poway","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"adb170dcda61ae66bbbb1df0"},"url":"https://jobsearcher.com/jobs/adb170dcda61ae66bbbb1df0"}}