Regulatory Affairs Specialist

QuidelOrtho

Regulatory Affairs Specialist ensuring regulatory compliance for diagnostic medical devices. Collaborating in maintaining regulatory infrastructure and processes within the organization.

Posted 5/27/2026full-timeSan Diego • California • 🇺🇸 United StatesSeniorLead💰 $77,399 - $85,000 per yearWebsite

About the role

Key responsibilities & impact

Assists with building and maintaining infrastructure and processes for operating the Clinical/Regulatory/Medical/Assay V&V department.
Manages US State licenses, US FDA registrations, EUDAMED registrations, and/or other facility registration processes.
Organizes regulatory records in eDMS, including US 510(k) files, CLIA Waiver Application files, and more.
Maintains trackers and reports on status of regulatory operations projects to management.
Performs other work-related duties as assigned.

Requirements

What you’ll need

7 years’ prior experience in IVD, Medical Device, Pharmaceuticals, or Biologics industries
15 years of administrative assistant experience
2 years of regulatory and quality experience (or equivalent)
Strong competency with Microsoft Office applications
strong competency in pdf publishing
strong competency in electronic document management systems.

Benefits

Comp & perks

medical, dental, vision, life, and disability insurance
401(k) plan
employee assistance program
Employee Stock Purchase Plan
paid time off (including sick time)
paid Holidays

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory experiencequality experienceIVDMedical DevicePharmaceuticalsBiologicseDMSpdf publishingMicrosoft Office