Senior Regulatory Specialists

About the role

The Sr. Regulatory Affairs Specialist will play a crucial role in ensuring Quanterix's IVD products comply with FDA and EU regulations. This position will focus on submissions, clinical protocol review, and product labeling review.

Responsibilities

• Preparation and timely completion of FDA submissions for in vitro diagnostic devices (assays, instruments, software)
• 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
• Audit and applicable documentation of changes in product, manufacturing processes, labeling affecting IVD products, including communication to project teams for impact assessment
• 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
• Review and approve promotional materials and product labeling

Requirements

• Bachelor's 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;
• Demonstrated ability maintaining global IVD Product, or other medical product gained through at least two (2) years of work experience.

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

Benefits

Hybrid schedule
Limited travel (up to 5-10% of the time, or as circumstances dictate)

Pay

Competitive compensation and a 401k plan with employer match, as well as competitive health, dental, and vision benefits for employees and their dependents.

Schedule

Flexible schedule to accommodate the needs of the team and the business.