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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...SuggestedFull timeLocal areaWorldwide
- ...Delegate and oversee QA work assignments to ensure compliance with statutory and regulatory requirements, including ISO 13485, FDA 21 CFR 210/211 cGMP, and IPEC Excipient standards Provide quality management oversight for existing products covering supply chain, production...SuggestedPermanent employment
- ...Regulatory & Standards Compliance ~ Ensure all relevant activities comply with applicable regulations and standards including: ~21 CFR 820 (Quality System Regulation) ~21 CFR 11 (Electronic Records & Signatures) ~ ISO 13485, ISO 14971 ~ IEC 62304 (Software...SuggestedFull timeContract work
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Limerick12 days ago - ...CAPA processes. Familiarity with regulated product development environments and quality systems ideally EN ISO 13485 MDR and FDA 21 CFR 820. Understanding of StageGate or Product Development Life Cycle methodologies. Soft Skills Strong leadership...SuggestedFull time
- ...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...SuggestedFull timeContract work
