Job Description Es esencial asegurarse de que cumple con los requisitos como solicitante para este puesto; por favor, lea atentamente la información a continuación. The Senior Regulatory Affairs Specialist is responsible for executing and maintaining EO Hub compliance activities for importers, distributors, and Authorised Representatives in accordance with applicable legislations. The role acts as a subject matter expert for the execution of processes related to device registrations, compliance verification activities, and the operational implementation of associated processes. The individual works with cross-functional stakeholders to ensure activities are completed accurately, consistently, and in accordance with applicable procedures and quality system requirements. Main responsabilities will include * Create, maintain, and update Authorised Representative mandates in accordance with applicable regulatory requirements and internal procedures. * Perform and support device registration and verification activities, ensuring required information is complete, accurate,
and aligned with applicable regulatory and quality system requirements. Support lifecycle updates of the records/registrations. * Request, track, and maintain Certificates of Free Sale (CFS). * Perform and support verifications required to comply with legislations within the EO Hub scope. * Document verification outcomes, follow up on identified gaps, and maintain applicable databases, trackers, and systems/tools to ensure accurate tracking of activities. * Contribute to the implementation and maintenance of effective controls to ensure ongoing compliance with applicable procedures, standards, and regulatory requirements. * Manage and/or contribute to continuous improvement projects, including process optimisation, simplification, standardisation, and effectiveness improvements. * Develop, maintain, and continuously improve associated job aids, work instructions, templates, trackers, and other quality s
📌 Sr. QRA Specialist (Barcelona)
🏢 BD
📍 Barcelona