Document Controller - IVDR

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Abbott in Ireland

Abbott has maintained a strong presence in Ireland since 1946 and celebrates its 80th anniversary in the country in 2026. The company supports the Irish healthcare sector with a broad portfolio spanning diagnostics, diabetes care, medical devices and nutritional products. Today, Abbott employs more than 6,200 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing which provides important information for the treatment and management of diseases and other conditions. IDEM is an over a billion-dollar business unit that now support significate growth for Abbott in COVID-19 related products in over 70+ countries.

We have an exciting opportunity as an  Associate Human Factors Engineer on a 12month fixed term contract and this role will involve the following

The role of Associate Human Factors Engineer is to support the development of innovative diagnostic products through user-centred design and usability engineering activities. This role offers exposure to the full human factors lifecycle, from user research and concept development through usability testing and validation, while working within a multidisciplinary product development team.

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