Senior Audit and Compliance Specialist New

Senior Audit and Compliance Specialist:

1. Must be able to freely travel therefore anyone with Stamp 4 visa won’t do unless they are about to obtain their Irish citizenship.
2. We need someone with good supplier audit experience
3. Medical devices industry would be the preference but happy to consider pharma.
4. Recruitment process: Kamila to screen, on-site interview with the hiring manager (we can’t do this interview via Teams), follow up interview with hiring manager’s 1 (this interview can be done remotely but they are welcome to come on-site if they are local)
5. Salary on the offer is 70k-80k depending on the experience
6. If they are not traveling, they have to be on-site in Galway (non-negotiable).

Senior Audit and Compliance Specialist

The Company

Its range of advanced technologies spans multiple healthcare disciplines, including diagnostics, medical devices, nutrition, and pharmaceuticals.

The Role

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.

• 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.

• 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.