Senior Regulatory Affairs Leader – Remote Eligible

QuidelOrtho; San Diego (CA); On-site; USD 105,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Paid time off

Paid holidays

Job summary

QuidelOrtho is seeking a Senior Regulatory Affairs Specialist to manage regulatory activities for new in vitro diagnostics and medical devices worldwide. You will lead regulatory submissions, interact with FDA and other agencies, and ensure compliance with QSR, ISO, CMDR, MDSAP, and IVDR/IVDD requirements.

The role supports cross-functional teams during development and lifecycle management projects, with remote-eligible work arrangements and opportunities to influence regulatory processes across

Qualifications

• Bachelor's degree in a scientific discipline is required.
• Experience with regulatory submissions and dossiers.
• Knowledge of FDA, IVDR, ISO, QSR, CMDR, MDSAP regulations.

Responsibilities

• Manage regulatory development and US submissions for medical devices/IVD.
• Lead regulatory strategy for market clearances with core teams.
• Prepare and review U.S./global submissions and regulatory docs.

Skills

Regulatory Affairs

FDA interactions

IVDR

GMP

QSR

ISO

CMDR

MDSAP

Leadership

Cross-functional

Documentation

Training

Change Control

RIMS

Data analysis

Microsoft Office

Education

Bachelor's degree in a scientific discipline

BS/BA in biological science

Tools

RIMS system

Job description

QuidelOrtho is seeking a Senior Regulatory Affairs Specialist to manage regulatory activities for new in vitro diagnostics and medical devices worldwide. You will lead regulatory submissions, interact with FDA and other agencies, and ensure compliance with QSR, ISO, CMDR, MDSAP, and IVDR/IVDD requirements.

The role supports cross-functional teams during development and lifecycle management projects, with remote-eligible work arrangements and opportunities to influence regulatory processes across