Remote Senior Regulatory Affairs Leader - Diagnostics

Ortho Clinical Diagnostics; United States; On-site; USD 150,000 - 170,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k)

Employee Stock Purchase Plan

Paid time off

Job summary

QuidelOrtho seeks a Senior Regulatory Affairs Manager to drive regulatory strategies for clinical laboratory and transfusion medicine products across development and lifecycle stages.

You will partner with R&D, quality, manufacturing, and clinical teams to ensure timely submissions and compliance with evolving global regulations, including EU IVDR, while mentoring junior staff and supporting continuous improvement.

Qualifications

• Bachelor’s degree required with 7+ years in regulatory affairs within the medical device or diagnostics industry.
• Proven track record as RA Functional Core Team Lead and managing complex regulatory submissions.
• Strong background in FDA, EU IVDR, and international regulatory requirements.
• Experience with regulatory submissions including 510(k), PMA, BLA, and TDF CE marking processes.

Responsibilities

• Interpret applicable regulatory requirements and apply them to project-level strategies for compliance and product registrations.
• Maintain and update regulatory plans aligned with evolving project needs.
• Assess risks, trade-offs, and strategic options and communicate recommendations to teams.
• Track regulatory commitments and ensure timely execution across programs.
• Prepare, review, and submit regulatory filings (FDA submissions, EU Technical Files, and international dossiers).
• Ensure documentation is complete, scientifically sound, and compliant with regulatory standards.
• Monitor changes in global regulations and provide guidance to project teams.
• Collaborate with global regulatory colleagues to support submissions and approvals.

Skills

Regulatory strategy

Cross-functional leadership

FDA regulations

EU IVDR

Program management

Risk assessment

Regulatory submissions

Regulatory documentation

Communication

Education

Bachelor’s degree

Job description

QuidelOrtho seeks a Senior Regulatory Affairs Manager to drive regulatory strategies for clinical laboratory and transfusion medicine products across development and lifecycle stages.

You will partner with R&D, quality, manufacturing, and clinical teams to ensure timely submissions and compliance with evolving global regulations, including EU IVDR, while mentoring junior staff and supporting continuous improvement.