Quality / Regulatory Associate

ABOUT CUREMETRIX - www.CureMetrix.com CureMetrix 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 OVERVIEW We'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. RESPONSIBILITIES • Quality system operations: • Manage controlled documents and records throughout their full lifecycle — creation, review, approval, revision, and archival • Administer training assignments and maintain training records within the QMS • Collaborate with technical experts to draft and review design documentation, including risk management and V&V materials • Support CAPA investigations, root cause analysis, and corrective action tracking • Assist with post-market surveillance and complaint handling documentation • Maintain quality records to ensure ongoing audit readiness and regulatory compliance • Support supplier documentation management and internal/external audit preparation • * Regulatory 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 documentation • Manage regulatory project tracking using Monday.com and other planning tools • Perform regulatory research to support market access and submission planning • Ensure document traceability, version control, and proper regulatory recordkeeping QUALIFICATIONS • Bachelor's degree in life sciences, engineering, or a related field • 2–3 years of experience in a regulated environment (medical device, biotech, life sciences, or healthcare) • Hands-on experience within an ISO 13485 quality management system • Prior experience in a fully remote or distributed professional environment REQUIRED SKILLS • Strong analytical, organizational, and documentation skills with exceptional attention to detail • Proficiency with Microsoft Office (Word, Excel, PowerPoint) • Comfortable owning operational tasks and driving them to completion with minimal supervision PREFERRED SKILLS • Familiarity with FDA 21 CFR Part 820 • Experience with an eQMS platform (e.g., Qualio) • Exposure to medical device regulatory submissions or audit support We'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.