Global Regulatory Affairs Leader, Diagnostics (Remote)

QuidelOrtho; New York (NY); On-site; USD 150,000 - 170,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) plan

Employee Stock Purchase Plan

Job summary

QuidelOrtho is seeking a Senior Regulatory Affairs Manager to drive regulatory strategy and execution across clinical laboratory and transfusion medicine products. You will partner with R&D, Quality, Manufacturing, and global teams to ensure timely submissions and compliance across development and lifecycle stages.

The role focuses on leading regulatory plans, managing risks, and delivering high-quality documentation for FDA, EU IVDR, and international authorities.

Qualifications

• Bachelor’s degree required.
• 7+ years of regulatory affairs experience in medical devices/diagnostics.
• Proven track record leading regulatory submissions (510(k), PMA, BLA, CE).
• Strong knowledge of FDA, EU IVDR, and international requirements.
• Excellent communication and project management skills.

Responsibilities

• Interpret regulatory requirements to support product registrations.
• Maintain regulatory plans aligned with project needs.
• Track commitments and ensure timely execution across programs.
• Prepare and submit regulatory filings (FDA, EU, and international).
• Ensure complete, scientifically sound documentation.
• Monitor changes in global regulations and advise teams.

Skills

Regulatory leadership

FDA regulations

Cross-functional collaboration

Project management

Education

Bachelor's degree

Advanced degree preferred

Job description

QuidelOrtho is seeking a Senior Regulatory Affairs Manager to drive regulatory strategy and execution across clinical laboratory and transfusion medicine products. You will partner with R&D, Quality, Manufacturing, and global teams to ensure timely submissions and compliance across development and lifecycle stages.

The role focuses on leading regulatory plans, managing risks, and delivering high-quality documentation for FDA, EU IVDR, and international authorities.