Job Description
Supports North America Regulatory activities. Ensures timely preparation and completion of technical file submissions for in vitro diagnostic devices (assays, instruments, software) to meet project and business needs. Ensures participation on cross functional project teams to provide strategic and tactical guidance to meet regulatory requirements. Develops North America regulatory strategies plan for submission for IVD products. Assesses changes to product, manufacturing processes, labeling affecting IVD products and communicate to global Regulatory and project teams for impact assessment. Supports global Regulatory teams and/or in-country dealers/representatives with regulatory registrations of IVD products. Maintains up-to-date knowledge of IVD regulations and applicable guidance, monitor development of regulations and communicate impact to the business. Provides input and feedback on clinical study protocols to ensure regulatory requirements are incorporated. Supports CE marking activities for IVD products and other market clearance for products manufactured globally. Reviews and approves promotional materials and product labeling. Supports importation/exportation permitting activities.
About Revvity
Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world’s greatest health challenges.