Hiring: Senior Regulatory Affairs Manager Company: QuidelOrtho Location: Kings County, NY Job Posted Time: 2026-09-10 15:08:20 Employment Type: Remote Target Skills & Keywords : Program Management, Project Management, R, Regulatory Compliance About the job Experience: •7 years plus of extensive experience in regulatory affairs within the medical device or diagnostics industry Required Skills: •The Sr Regulatory Affairs Manager plays a critical role in enabling operational excellence, maintaining compliance with evolving global regulations (including EU IVDR requirements), and contributing to continuous improvement initiatives within the regulatory function, while supporting team collaboration and development. •Responsible for planning, tracking, and delivering regulatory milestones, ensuring alignment with project timelines, and supporting leadership in identifying and escalating key regulatory risks and compliance issues. •This position is remote eligible for candidates located in the United States. •Interpret applicable regulatory requirements and apply them to project-level strategies to support compliance and product registration •Maintain and update regulatory plans, ensuring alignment with evolving project needs and regulatory expectations •Assess risks, trade-offs, and strategic options, and communicate recommendations to project teams and management •Track regulatory commitments and ensure timely execution across assigned programs •Support preparation and coordination of regulatory activities in partnership with internal teams and external stakeholders Qualifications: •Advanced degree preferred in relevant scientific, regulatory, or related field •R&D departments, Business Units, Quality, Manufacturing, Clinical teams, Legal, International Regulatory Affairs •External consultants and regulatory agencies •Typical office environment, including home office. 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!