12 months FTC **About Abbott** Abbott is a global healthcare leader, we are committed to helping people live their best possible life through the power of health. For more than 135 years, we have brought new products and technologies to the world: in diagnostics, nutrition, cardiovascular, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today our 115,000 Abbott colleagues are working to help people live not just longer, but better, in the more than 160 countries we serve. **Abbott in Ireland** Abbott serves the Irish market with a diverse range of healthcare products, including diagnostics, medical devices, and nutritional products. In Ireland, Abbott employs over 6,000 people across ten sites. We have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Kilkenny, Longford, and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations, and shared services in Dublin and Galway. We have been operating in Ireland since 1946. **PURPOSE OF THE JOB** The Document Controller will be responsible for supporting the assessment and implementation of change control activities for products and processes under the centralized Change Control Board (CCB). Acting as subject matter experts on change implementation, the Document Controller will ensure changes comply with IVDR and other regulatory requirements. They will conduct detailed reviews, risk assessments, and data analysis to facilitate informed decision-making and successful implementation of changes. The position reports to the Quality Project Manager and the role is based in Galway. **Responsibilities and Duties:** · Perform detailed reviews of Change Requests (CRs) and Change Orders (COs) in Agile PLM. · Conduct impact assessments for changes, ensuring alignment with IVDR and other regulatory requirements. · Provide region-specific expertise to ensure changes meet local legal manufacturer (LM) needs. · Identify potential risks associated with proposed changes and document mitigation strategies. · Collaborate with the Change Coordinator to prepare risk assessment documentation and dashboards. · Work with Regulatory Affairs, Quality Assurance, Manufacturing, R&D, and other stakeholders to align on change control strategies. · Participate in cross-functional assessments to address technical and regulatory considerations. · Ensure accurate and complete documentation of change control activities. · Support the development of standardized templates and procedures for change documentation. · Responsible for maintaining the QMS documentation program and also responsible for the control and distribution of records and overseeing the implementation of quality documents. · Review and coordinate to ensure that all submitted documents meet the standards and requirements of the QMS. Approve administrative changes to controlled documents for Quality Assurance Team. · Standardize the writing of document records and the requirement for review and approval. Provides guidance on format, style and architecture of documents to enhance standardisation and clarity and to minimize unnecessary updates. · Assist in the drafting, approval and distribution of other quality system documents and promote the consistency of quality management. · Participate and support internal and external audits across the Business Unit (BU). **Required Qualifications:** · Bachelor’s degree in Quality Assurance, Regulatory Affairs, Life Sciences, Engineering, or a related field. · 1-2 years of experience in change control, quality assurance, or document control in a regulated industry. · Hands-on experience with Agile PLM or equivalent change/document management systems. · Strong understanding of IVDR (In Vitro Diagnostic Regulation) requirements. · Excellent organizational and time management skills. · Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). · Strong written and verbal communication skills. **Preferred Qualifications** · Experience creating dashboards, generating reports, and performing data analysis to track change control metrics. · Knowledge of Tableau, Power BI, or similar tools for data visualization is a plus. · Prior experience working with global regulatory requirements in addition to IVDR. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com