Senior Regulatory Affairs Manager (Remote)

QuidelOrtho Corporation; United States; Remote; USD 150,000 - 170,000; Full time

Job summary

QuidelOrtho, a world-leading in vitro diagnostics company, seeks a Senior Regulatory Affairs Manager in the United States. You will drive regulatory planning, execution and submissions for clinical laboratory and transfusion medicine products across development and lifecycle stages, partnering with cross-functional teams and global regulators.

You translate requirements into actionable plans, manage timelines, and ensure high-quality documentation for FDA, EU IVDR and international agencies,

Qualifications

• Bachelor’s degree required.
• 7+ years of regulatory affairs experience in medical devices or diagnostics.
• Proven track record leading regulatory submissions and cross-functional teams.
• Strong knowledge of FDA and EU IVDR requirements.
• Excellent communication and leadership abilities.

Responsibilities

• Interpret regulatory requirements to support project-level strategies and registrations.
• Maintain regulatory plans aligned with evolving needs and expectations.
• Track commitments and ensure timely regulatory execution across programs.
• Prepare and submit regulatory filings (FDA, EU, and international).
• Provide guidance to project teams during development and lifecycle management.
• Collaborate with global regulatory colleagues for submissions and approvals.
• Mentor junior staff and coordinate with consultants and external partners.

Skills

Regulatory strategy

Cross-functional leadership

FDA & EU IVDR

Project management

Communication skills

Education

Bachelor’s degree

Job description

QuidelOrtho, a world-leading in vitro diagnostics company, seeks a Senior Regulatory Affairs Manager in the United States. You will drive regulatory planning, execution and submissions for clinical laboratory and transfusion medicine products across development and lifecycle stages, partnering with cross-functional teams and global regulators.

You translate requirements into actionable plans, manage timelines, and ensure high-quality documentation for FDA, EU IVDR and international agencies,