QuidelOrtho
QuidelOrtho is seeking a Regulatory Affairs (RA) Specialist to support regulatory submissions and product licensing activities for in vitro diagnostics/medical device products, with a strong focus on Korea’s MFDS. The role supports delivery of an overall regulatory plan and works closely with internal stakeholders and external agencies to enable timely registrations and ongoing product compliance. Over time, the position may expand into more strategic regulatory responsibilities as capability grows.
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.
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Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
View leadership team, funding history,
and employee contacts for QuidelOrtho.
QuidelOrtho didn’t post a salary, so this is our estimate from similar listings.
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