Regulatory Affairs Officer: IVDR/ISO 13485 Expert

Abbexa is seeking a Regulatory Affairs Officer to develop and maintain a Quality Management System compliant with ISO 13485 for medical devices. The role involves overseeing regulatory submissions for UK and EU product development and ensuring compliance with evolving regulations.

The ideal candidate should have at least 2 years of experience in a regulated environment, knowledge of IVDR processes, and excellent organizational skills. This full-time position is based in Bar Hill and offers competitive benefits, including 21 days holiday and a healthcare package.

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