Hiring: Senior Regulatory Affairs Manager Company: QuidelOrtho Location: Kings County, NY Job Posted Time: 2026-09-16 18:08:19 Employment Type: Remote Target Skills & Keywords : Microsoft Excel, Microsoft Office, Microsoft PowerPoint, R, Regulatory Compliance, Visio About the job Experience: •Demonstrated technical expertise with immunoassay and molecular diagnostics is preferred. •Typical office environment, including home office. Required Skills: •This position is remote eligible for candidates located in the United States. •Manages new product development and U.S. submissions activities for a set of medical devices and/or IVD products. •Works as primary core team member on new molecular product development teams and establishes regulatory strategy to achieve market clearance. •Prepares, reviews and approves U.S. (FDA) product submissions; reviews and approves other regulatory documentation generated during the new product development effort to support international product submissions and registrations. •Supervises interactions with government agencies for regulatory submissions. •Reviews and approves verification and validation protocols and reports; advises on best practices for data presentation in regulatory submissions. •Reviews and approves Marketing/Sales literature and labeling. •Establishes and/or owns regulatory affairs processes and acts as subject matter expert during inspections. Qualifications: •BS/BA in a biological science •Minimum of 8 years’ experience in the IVD or medical device manufacturing environment Compensation: •Flexible work environment (work from home / hybrid options) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!