Senior Regulatory Affairs Manager

The Opportunity

Quidel Ortho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

At Quidel Ortho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next Senior Regulatory Affairs Manager. The Senior Regulatory Affairs Manager is responsible for driving the planning, execution, and delivery of regulatory activities supporting clinical laboratory and transfusion medicine products across development and lifecycle stages. This role partners closely with cross-functional teams and global regulatory stakeholders to ensure timely submissions, regulatory compliance, and alignment with product development objectives.

Serving as a key contributor to regulatory strategy, the Sr RA Manager translates regulatory requirements into actionable plans, manages timelines and deliverables, and identifies risks while supporting informed decision-making. This role also ensures high-quality preparation and submission of scientifically sound regulatory documentation to health authorities, including FDA, EU Notified Bodies, and international agencies.

The Sr Regulatory Affairs Manager plays a critical role in enabling operational excellence, maintaining compliance with evolving global regulations (including EU IVDR requirements), and contributing to continuous improvement initiatives within the regulatory function, while supporting team collaboration and development.

The Senior Regulatory Affairs Manager develops, communicates, and executes regulatory strategies for clinical laboratory and transfusion medicine products across development and lifecycle management. This role supports regulatory operations and strategic initiatives while collaborating with cross-functional teams and global regulatory partners to ensure compliance and timely product registrations. The position contributes to regulatory excellence by aligning program deliverables with organizational goals and maintaining awareness of regulatory risks and requirements.

The Senior Regulatory Affairs Manager is responsible for planning, tracking, and delivering regulatory milestones, ensuring alignment with project timelines, and supporting leadership in identifying and escalating key regulatory risks and compliance issues.

This position is remote eligible for candidates located in the United States.

• Interpret applicable regulatory requirements and apply them to project-level strategies to support compliance and product registration
• Maintain and update regulatory plans, ensuring alignment with evolving project needs and regulatory expectations
• Assess risks, trade-offs, and strategic options, and communicate recommendations to project teams and management
• Track regulatory commitments and ensure timely execution across assigned programs
• Support preparation and coordination of regulatory activities in partnership with internal teams and external stakeholders
• Prepare, review, and submit regulatory filings (e.g., FDA submissions, EU Technical Files, and international dossiers) in…