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Sr Regulatory Affairs Manager at QuidelOrtho - ApplyBlast

Sr Regulatory Affairs Manager

QuidelOrtho

8 months ago

3.4 on Glassdoor

United States

Hybrid

Full Time

Senior

0 applicants

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About this role

This role at QuidelOrtho involves managing regulatory activities for in vitro diagnostics and medical devices, supporting product development, regulatory submissions, and compliance. The position requires collaboration with cross-functional teams and regulatory agencies to ensure product approval and adherence to worldwide regulations.

Skills

Qualifications

BS in a scientific discipline12 years experience in IVD/medical device industryExperience in regulatory documentation and submissionsLeadership in regulatory disciplinesInteraction with FDA and global agencies

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.