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
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- 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 qua
📌 Sr. QRA Specialist (Barcelona)
🏢 BD
📍 Barcelona