Regulatory Affairs Lead – Medical Devices & IVD (Remote)

QuidelOrtho; New York (NY); On-site; USD 105,000 - 120,000; Full time

Job summary

QuidelOrtho seeks a Senior Regulatory Affairs Specialist to lead regulatory activities for new in‑vitro diagnostics and medical devices in worldwide markets. You will manage U.S. submissions, interact with FDA and global agencies, and ensure compliance with QSR, ISO, CMDR, IVDR, and CFR requirements. This role is remote eligible.

The position requires leadership, cross‑functional collaboration, and the ability to work independently on high visibility projects across regulatory disciplines.

Qualifications

• Bachelor's degree in a scientific discipline.
• 4+ years in the IVD/medical device or bio/pharma manufacturing sector.
• 3+ years in Regulatory Affairs with leadership responsibilities.
• Experience preparing regulatory documentation including 510(k), international registrations, and EU technical files.
• Experience as a core team member on product development projects.
• Direct interaction with FDA and other regulatory agencies.
• Strong knowledge of GMP and quality systems.
• Proficiency with MS Office.
• Not currently eligible for visa sponsorship.

Responsibilities

• Lead regulatory activities for new product development and US submissions.
• Serve as core team member on development programs and define regulatory strategy.
• Prepare and review US (FDA) and global submissions; support international filings.
• Conduct IVDR submissions and gap assessments.
• Manage government agency interactions for regulatory submissions.
• Review marketing literature and labeling for compliance.
• Establish regulatory processes and act as SME during inspections.
• Develop training materials on regulatory requirements.
• Evaluate change control documents for regulatory impact.
• Research regulations and summarize for departmental use.

Skills

Regulatory submissions

FDA interactions

Leadership

Cross-functional collaboration

Attention to detail

Communication skills

Independent work

Problem solving

Education

BS/BA in a scientific discipline

BS/BA in a biological science

Tools

Microsoft Office (Word, Excel, PowerPoint, Visio)

Job description

QuidelOrtho seeks a Senior Regulatory Affairs Specialist to lead regulatory activities for new in‑vitro diagnostics and medical devices in worldwide markets. You will manage U.S. submissions, interact with FDA and global agencies, and ensure compliance with QSR, ISO, CMDR, IVDR, and CFR requirements. This role is remote eligible.

The position requires leadership, cross‑functional collaboration, and the ability to work independently on high visibility projects across regulatory disciplines.