Regulatory Affairs Specialist

Company Description AgaMatrix is a leader in innovative diabetes care, having manufactured over 8 million devices and developed cutting-edge solutions like the first FDA-cleared blood glucose meter/app for iPhone®. Collaborating with prominent global partners such as CVS, Kroger, Sanofi, and Perrigo, we aim to redefine diabetes management through advanced biosensor technology and connected health solutions. Our team of scientists, designers, and engineers is committed to delivering intelligent, high-accuracy tools that go beyond testing to improve patient outcomes. Based in Derry, NH, our mission is driving continuous innovation to shape the future of diabetes care. Role Description This is a full-time, on-site role in Derry, NH, for a Regulatory Affairs Specialist. The role entails preparing and submitting regulatory documentation, ensuring adherence to regulatory requirements, and maintaining compliance with global and domestic regulations. The specialist will support regulatory submissions, oversee product compliance, and collaborate across departments to manage certifications and standards. Additionally, this position involves monitoring regulatory changes and ensuring smooth adaptation within the organization. Qualifications Expertise in Regulatory Documentation, Submission preparation, and filing processesKnowledge of Regulatory Compliance and Regulatory Requirements for medical devices or healthcare productsHands-on experience in Regulatory Affairs, including maintaining certifications and compliance with global and domestic standardsExperience in interpreting and implementing new and updated Regulatory RequirementsStrong attention to detail, organizational skills, and the ability to manage multiple projects simultaneouslyBachelor’s degree in a scientific, engineering, or related fieldFamiliarity with FDA, ISO, EU MDR guidelines and medical device regulations is highly beneficialEffective communication skills and ability to collaborate across teams