Global RA Specialist
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About The Position
CooperVision, Inc. seeks a Global RA Specialist in Victor, NY to coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. The role involves coordinating efforts associated with the preparation of regulatory documents or submissions, communicating with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. The specialist will prepare additional information or responses as requested by regulatory agencies and coordinate, prepare, or review regulatory submissions for domestic or international projects. Additionally, the role includes preparing or maintaining technical files as necessary to obtain and sustain product approval, supporting global vigilance activities focusing on Adverse Event monitoring and reporting, and generating Periodic Safety Update Reports (PSUR) and templates. The specialist will also maintain regulatory files for adverse event/incident reporting, recall, and post-market surveillance, and analyze and improve processes that are used to handle adverse event/incident reporting, post market surveillance, and recall.
