Regulatory Affairs Specialist

QuidelOrtho is seeking a Regulatory Affairs Specialist to join their team in San Diego, CA. The successful candidate will be responsible for managing US State licenses, US FDA registrations, EUDAMED registrations, and other facility registration processes. They will work cross-functionally to provide decisions on orders in the SAP system and update license information.

Requirements

• 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, pdf publishing, and electronic document management systems

Benefits

• 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