QA/RA Specialist with IVDR experience. Irlanda

We are looking for a part – time or full -time Medical Device Quality Assurance Specialist with background in Biotechnology, biomedical science or similar, a strong knowledge of ISO 13485 and IVDR to join our QA/RA team in Ireland. FDA experience desirable. To work remotely , flexible hours, salary to be negotiated.

Responsibilities

    Support the maintenance of ISO 13485

    Support risk management activities in accordance with ISO 14971

    Conduct internal audits of QMS in order to identity good practices, risks and opportunities for improvement.

    Assist in selection and approval of suppliers/sub-contractors.

    Assist in the development of technical documentation and other regulatory compliance activities.

    Assist with CE marking products under IVDR

Requirements

    Strong knowledge of ISO 13485, ISO 14971

    Minimum 3 years’ experience in Quality Systems in the Medical Device Industry

    3rd Level qualification

    Biotechnology, biomedical science background or similar

Desirable

    Knowledge of 510k and De Novo FDA applications  

    Working Knowledge of Entropy software solutions

    IVDR and Sales experience