Senior Regulatory Specialist

# Senior Regulatory Specialist # Billerica, MA Quanterix is a global leader in ultra-sensitive biomarker detection, enabling breakthroughs in disease research, diagnostics, and drug development. Its vision is to lead the next era of precision biomarker science to power earlier detection, better decisions, and improved human health. Its mission is to make biology measurable at its most fundamental level, delivering earlier insight when it matters most. Across discovery to clinical applications, Quanterix empowers scientists and healthcare providers to improve patients’ lives through detection and understanding of disease. Its proprietary Simoa® technology delivers industry-leading sensitivity, allowing researchers to detect and quantify biomarkers in blood and other fluids at concentrations far below traditional limits. With more than 3,400 peer-reviewed publications, Quanterix has been a trusted partner to the scientific community for nearly two decades. In 2025, Quanterix acquired Akoya Biosciences, The Spatial Biology Company®, adding multiplexed tissue imaging with single-cell resolution to its portfolio. Together, the combined company offers a uniquely integrated platform that connects biology across blood and tissue—advancing precision medicine from discovery to diagnostics. We are looking for an experienced and highly motivated **Sr. Regulatory Affairs Specialist** located in **Billerica, MA** to join our **(Regulatory Affairs Team)**. Quanterix is seeking a talented and highly motivated Regulatory Affairs Specialist to join our growing group. This role will be responsible for IVD product submissions, clinical protocol review and product labeling review. **What You’ll Do:** - Preparation and timely completion of FDA submissions for in vitro diagnostic devices (assays, instruments, software) to meet project and business needs (Q-Submission, 510(k), de Novo, EUA supplement, Break Through Device, etc.) - Participation on cross functional project teams to provide strategic and tactical guidance to meet US FDA and EU IVDR requirements. - Support global regulatory plan for IVD products - Assessment and applicable documentation of changes in product, manufacturing processes, labeling affecting IVD products, including communication to project teams for impact assessment - Support global Regulatory teams and/or in-country dealers/ representatives with regulatory registrations of IVD products - Maintain up-to-date knowledge of IVD regulations and applicable guidance’s, monitor development of regulations and communicate impact to the business - Provide input and feedback on clinical and analytical study protocols and reports to ensure regulatory requirements are incorporated - Act as FDA liaison for US submissions and other interactions regarding regulatory matters, including preparing for and attending meetings with the FDA as required - Support CE marking activities for IVD products - Review and approve promotional materials and product labeling **What We’ll Expect From You:** **Basic Qualifications:** - Bachelors Degree in life science related field (Medical Technology, Chemistry, Biology, biomedical engineering) - Minimum of 4 years’ experience in Medical Device or IVD Regulatory Affairs **Preferred Qualifications:** - Demonstrated knowledge of FDA regulations and guidance documents including 21CFR 820, ISO 13485, cGXP guidelines, and CLSI gained through at least two (2) years of work experience; - Demonstrated ability supporting FDA and CE registrations gained through at least two (2) years of work experience; - Demonstrated knowledge of FDA Product approvals, EU Product Approvals, and CLIA/CAP certifications gained through at least two (2) years of work experience; - Demonstrated knowledge of FDA and State Inspections gained through at least two (2) years of work experience; and - Demonstrated ability maintaining global IVD Product, or other medical product gained through at least two (2) years of work experience. **Expectat…