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Senior Regulatory Affairs Manager at QuidelOrtho - ApplyBlast

Senior Regulatory Affairs Manager

QuidelOrtho

2 months ago

3.4 on Glassdoor

Remote

Full Time

Senior

2 applicants

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About this role

The Senior Regulatory Affairs Manager at QuidelOrtho leads regulatory activities for the development and approval of in vitro diagnostics and medical devices in the worldwide market. This role involves managing U.S. and IVDR regulatory submissions, ensuring compliance with global quality and regulatory standards, and serving as a subject matter expert during inspections. The position requires close collaboration with cross-functional teams to drive new product development and lifecycle management projects.

Responsibilities

Manage regulatory activities for new in vitro diagnostics and medical devices
Prepare and review FDA product submissions and international registrations
Supervise interactions with government agencies for regulatory clearances

Skills

Qualifications

BS/BA in a scientific disciplineBS/BA in a biological science

About QuidelOrtho

quidelortho.com

Company Size

5001-10000 employees

Founded

1937

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QuidelOrtho is a global diagnostics company that provides vital health information across the entire healthcare continuum, from home to hospital and lab to clinic. The company offers a broad portfolio of diagnostic solutions including point-of-care rapid tests, immunohematology systems, molecular diagnostics platforms, clinical chemistry and immunoassay analyzers, and lab management software. QuidelOrtho's products — such as the VITROS™, SOFIA™, ORTHO VISION™, and QUICKVUE™ lines — are designed to deliver fast, accurate, and actionable results to improve patient care, safety, and treatment decisions.