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.

Expectations, Skills & Abilities:

• Apply sound judgment to regulatory strategy, submissions, and labeling decisions.
• Partner cross-functionally to support project goals and regulatory compliance.
• Adapt to changing priorities while maintaining accuracy and attention to detail.
• Communicate complex regulatory topics clearly to varied audiences.
• Use strong analytical skills to assess risk and recommend compliant solutions.
• Demonstrate accountability, professionalism, and discretion.
• Build strong working relationships through proactive, solutions-oriented communication.
• Hybrid schedule
• Limited travel (up to 5-10% of the time, or as circumstances dictate)

Why You’ll Like Working For Us:

Our Technology:

From discovery to diagnostics, Quanterix’s ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. Simoa® technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Level of Quantification (LoQ). Our industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology, and infectious disease.

Akoya Biosciences, a Quanterix company, is The Spatial Biology Company®—bringing tissue context to life through high-resolution, single-cell imaging. Akoya’s spatial phenotyping platforms help researchers visualize and measure how cells organize and interact within tissue to influence disease progression and therapeutic response. From discovery through clinical research, Akoya offers a full continuum of solutions, including PhenoCycler®, PhenoImager® Fusion and HT, and PhenoCode™ Panels. As part of Quanterix, Akoya complements a leading portfolio of ultra-sensitive biomarker detection technologies, together enabling a more complete view of biology and disease across both tissue and blood.

Our Commitment to Employees:

At Quanterix, our values are based on: Team, Innovation, Customer and Owner.

Team: Challenge assumptions, not the person. Respect diversity of thought and hold ourselves to lofty standards

Innovation: Stay curious, experiment, create and change

Customer: Prioritize and celebrate these pioneers by doing our best to deliver on commitments

Owner: Act with high integrity and in the best interest of Quanterix. Take measured risks and learn from their success and failures.

We reward and recognize our employees by offering competitive compensation and a 401k plan with employer match, as well as competitive health, dental, and vision benefits for employees and their dependents. We also offer an unlimited vacation policy to all exempt employees, and a generous PTO policy for non-exempt employees. All employees are eligible for equity, employee stock purchase plan, a performance bonus, and 1:1 financial counseling/planning. We also offer Tuition Assistance. We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free snacks and drinks every day!

DIVERSE & INCLUSIVE WORKPLACE:

Quanterix is committed to a Diverse and Inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values. Quanterix is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Quanterix will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.