Senior Regulatory Specialists

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: