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  • Director, Post-Market Surveillance and Clinical Evaluation

     ...global operational priorities. Oversee and ensure that all PMS & CE activities comply with applicable regulations including FDA (21 CFR Part 801 21 CFR Part 820) EU MDR/IVDR (Annex I II) and regional requirements across APAC LATAM and MEA. Proactively monitor regulatory... 
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    Full time
    Local area
    Worldwide

    Cook Group

    Limerick
    6 days ago

  • Principal Data Engineer

     ...platforms related to AI/GenAI. Proficiency in star schemas and data modeling tools. Knowledge of industry regulatory requirements (CFR Part 11, GxP, CSA). Stream processing experience (Kafka, Flink). Cloud certifications. In order to be considered for this... 
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    Permanent employment
    Local area

    Regeneron

    County Limerick
    22 days ago

  • Lead Mechanical Design Engineer

     ...processes. Familiarity with regulated product development environments and quality systems, ideally EN ISO 13485, MDR, and FDA 21 CFR 820. Understanding of Stage‑Gate or Product Development Life Cycle methodologies. Soft Skills Strong leadership capability... 
    Suggested

    Innovate Skillsource

    Limerick
    9 days ago

  • Staff IT Compliance Analyst

     ...and cross-functional expertise. This role may be for you if you have:   A deep understanding of GxP regulations (e.g., FDA 21 CFR Part 11, EU Annex 11) and expertise in IT system validation and qualification processes. Proven ability to apply quality assurance principles... 
    Suggested
    Permanent employment
    Local area

    Regeneron

    County Limerick
    23 days ago

  • Senior Manager IT Applications - Run

     ...leading QC laboratory informatics in a cGMP/GxP environment, including run operations for LIMS, CDS, SDMS/ELN/LES. Strong knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, CSV practices, data integrity principles (ALCOA+), and audit readiness. Hands-on administration... 
    Suggested
    Permanent employment
    Local area
    Night shift

    Regeneron

    County Limerick
    13 days ago

  • Senior Software Quality Engineer

     ...a subject matter expert for software quality, ensuring deliverables meet customer expectations and regulatory requirements such as 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, and EU MDR . Key Responsibilities Develop and maintain strategies to improve software... 
    Suggested
    Full time
    Contract work

    Innovate Skillsource

    Limerick
    a month ago