Senior Audit and Compliance Specialist

The Company Our client is a leading organisation supporting the Irish healthcare sector, offering a diverse portfolio across areas such as diagnostics, chronic disease management, medical technologies, and nutritional solutions. The company is recognised globally for delivering innovative healthcare services and products that enhance quality of life at every stage. Its range of advanced technologies spans multiple healthcare disciplines, including diagnostics, medical devices, nutrition, and pharmaceuticals. The Role The Senior Audit & Compliance Specialist role sits within a specialised business unit focused on infectious disease and reports to the Manager of Audits and Inspection Readiness. The successful candidate will support the supplier audit programme and lead supplier audits across multiple sites within the division. This position plays a key role in ensuring continuous inspection readiness and maintaining compliance with relevant regulatory frameworks, including international medical device and quality standards such as MDSAP and MDR/IVDR. Key responsibilities:

• Assist with the organisation’s Quality Management System by ensuring that audit programmes (supplier, internal, and external) comply with internal policies and applicable external standards and regulations.
• Coordinate and conduct supplier audits, including planning, execution, and timely reporting through to closure, in line with site and organisational requirements. Work independently with sites to define audit scope and carry out assessments.
• Maintain audit schedules and performance metrics at a business unit level; monitor and trend audit findings to identify recurring or systemic issues.
• Support sites in implementing and sustaining inspection readiness activities.
• Prepare for and support external inspections and internal audits, including logistics coordination, documentation review, stakeholder support, and coaching of auditees.
• Apply analytical and critical thinking to support resolution of aged corrective and preventive actions (CAPAs), complaint investigations, and field-related actions arising from audits or inspections.
• Contribute to continuous improvement initiatives within the quality system and provide support for regulatory submissions where required.
• Participate in full-scope Quality Management System audits to ensure ongoing compliance with internal and external standards and regulatory requirements.
• Demonstrate professional conduct in all interactions with internal and external stakeholders, ensuring alignment with organisational values, policies, and best practices.

Basic Qualifications– Education / Experience / Skills

• Level 8 degree in life science, engineering, or quality assurance-related field.
• A minimum of 5 years of experience in a regulated manufacturing environment, preferably in a Quality or Regulatory role.
• Strong contemporary knowledge of relevant MDSAP, MDR/IVDR, cGMP Regulations and current industry trends.
• Experience in independently conducting and leading supplier audits
• Experience in Technical Documentation compilation/review for compliance with MDR/IVDR.
• Experience in supporting external inspections and corporate audit.

Key Skills And Behaviours

• Ability to work independently and collaboratively in a fast-paced environment.
• Ability to analyse and resolve business and compliance issues using independent judgment.
• Excellent organisational, communication, and problem-solving skills.
• Attention to detail and the ability to analyse information to identify patterns
• Ability to travel 40-50%
• Able to use Word, Excel, PowerPoint Point and Outlook.