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  •  ...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... 
    Suggested
    Full time
    Local area
    Worldwide

    Cook Group

    Limerick
    6 days ago
  •  ...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... 
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    Innovate Skillsource

    Limerick
    9 days ago
  •  ...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