Document Controller - IVDR

About Abbott

Abbott is an international healthcare company dedicated to enhancing lives at all life stages. It offers a comprehensive range of groundbreaking healthcare technologies, including diagnostics, medical devices, nutrition, and branded generics, employing 122,000 people across more than 160 countries.

In Ireland, Abbott has been active since 1946 and marks its 80th year in 2026. The company supports Ireland's healthcare sector with extensive product lines in diagnostics, diabetes care, medical devices, and nutritional products, employing over 6,200 individuals across ten locations including Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford, and Sligo.

Abbott Rapid Diagnostics is a segment within Abbott’s Diagnostics business, combining expert teams and innovative technologies to provide key diagnostic testing to inform disease treatment and management. The IDEM business unit contributes significantly to Abbott’s growth, especially in COVID-19 related products available in over 70 countries.

Position Overview

The Document Controller role focuses on supporting regulatory compliance and quality management related to the In Vitro Diagnostic Regulation (IVDR). The position emphasizes detailed review and management of change requests and orders within Agile PLM, ensuring adherence to regulatory standards and quality systems documentation.

Key Responsibilities

• Conduct thorough evaluations of Change Requests (CRs) and Change Orders (COs) using Agile PLM.
• Assess the impact of proposed changes while ensuring compliance with IVDR and other regulations.
• Provide expertise tailored to regional regulatory requirements as a legal manufacturer.
• Identify risks linked to changes and develop plans to mitigate them.
• Coordinate with Change Coordinators to prepare risk assessments and reporting dashboards.
• Collaborate extensively with Regulatory Affairs, Quality Assurance, Manufacturing, R&D, and other departments to align on change control approaches.
• Engage in cross-functional evaluations covering technical and regulatory aspects.
• Ensure all change control documents are accurately maintained and complete.
• Support the creation and adoption of standardized documentation templates and procedures.
• Oversee Quality Management System (QMS) documentation, including control, distribution, and implementation of quality records and documents.
• Review submitted documentation to ensure it fulfills QMS standards and requirements; approve administrative updates to controlled documents for the Quality Assurance team.
• Standardize formatting, style, and structure of document records to promote clarity, reduce unnecessary revisions, and improve consistency.
• Assist in drafting, approving, and circulating other quality system documents to maintain uniformity in quality management.
• Contribute to internal and external audit activities throughout the Business Unit (BU).

Essential Qualifications

• Bachelor’s degree in Quality Assurance, Regulatory Affairs, Life Sciences, Engineering, or associated disciplines.
• 1 to 2 years of practical experience in change control, quality assurance, or document control within a regulated environment.
• Proficient with Agile PLM or similar change/document management software.
• Comprehensive understanding of IVDR compliance obligations.
• Strong organizational capabilities and effective time management.
• Good command of Microsoft Office applications including Word, Excel, and PowerPoint.
• Excellent communication skills, both written and oral.

Preferred Skills

• Experience in producing dashboards, reports, and conducting data analysis related to change control metrics.
• Familiarity with data visualization tools such as Tableau or Power BI is advantageous.
• Background in working with international regulatory frameworks beyond IVDR is beneficial.