Senior Regulatory Affairs Leader – IVD/Devices (Remote)

QuidelOrtho; New York (NY); On-site; USD 170,000 - 185,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with match

Employee Stock Purchase Plan

Paid time off

Job summary

QuidelOrtho is seeking an experienced Senior Regulatory Affairs Manager to advance regulatory activities for new in vitro diagnostics and medical devices worldwide. You will lead U.S.

submissions, interact with FDA and other agencies, and ensure compliance with QSR, ISO, IVDR, and related regulations. This remote-eligible role supports U.S.-based development teams and requires deep regulatory expertise, strong leadership, and the ability to drive processes across functions to meet market

Qualifications

• Bachelor's degree in a scientific discipline.
• Minimum 12 years of experience in the IVD/medical device/bio/pharma manufacturing environment.
• Minimum 12 years in Regulatory Affairs with progression of responsibility and leadership.
• Experience with preparation and submission of regulatory documentation including 510(k) submissions and international registrations.
• Experience as a core team member on product development teams.
• Direct interaction with FDA and other regulatory agencies.
• Advanced knowledge of GMP and quality systems in manufacturing.
• Ability to work with cross-functional teams.

Responsibilities

• Manages development and U.S. submissions for medical devices and IVD products.
• Leads regulatory strategy on new molecular product development teams.
• Prepares and reviews U.S. (FDA) submissions and supports international filings.
• Interacts with government agencies for regulatory submissions.
• Reviews and approves verification/validation data for regulatory submissions.
• Reviews marketing literature and labeling for regulatory compliance.
• Develops and implements regulatory processes and training materials.
• Ensures regulatory records are organized and up-to-date.
• Communicates regulatory requirements across departments.

Skills

Regulatory leadership

Written communication

Cross functional collaboration

Attention to detail

Education

Bachelor's degree in a scientific discipline

Tools

Microsoft Office

Visio

Job description

QuidelOrtho is seeking an experienced Senior Regulatory Affairs Manager to advance regulatory activities for new in vitro diagnostics and medical devices worldwide. You will lead U.S.

submissions, interact with FDA and other agencies, and ensure compliance with QSR, ISO, IVDR, and related regulations. This remote-eligible role supports U.S.-based development teams and requires deep regulatory expertise, strong leadership, and the ability to drive processes across functions to meet market