Job Description
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 system documentation.
- Support internal and external audits, inspections, and regulatory assessments by providing documentation, expertise, and re
📌 Sr. QRA Specialist (Barcelona)
🏢 BD
📍 Barcelona