Medical Device Specialist – Batch Release

Site Name: Ireland - Dublin
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Posted Date: Apr 10 2026

We are looking for a medical device specialist to join our team on a 12-month fixed term contract basis.

The successful candidate will prepare and review batch verification dossiers for medical devices supplied globally. You will work with manufacturing sites, external quality, supply chain and regulatory teams to ensure timely and compliant batch verification.

We value people who are curious, dependable and clear communicators. This role offers strong learning and growth opportunities and a chance to make a meaningful impact by helping ensure safe and effective products reach patients. Join us to unite science, technology and talent to get ahead of disease together.

It is offered on a hybrid basis – you will work from the Dublin, Ireland site and from home as agreed with your manager.

Benefits: competitive salary, annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, shares and savings programme.

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• Prepare and review batch dossiers for medical device verification, including manufacturing, packaging and test records.
  
• Ensure batches verified are maintained, and dossiers and samples archived in accordance with local SOPs and MDR 2017/745 requirements.
  
• Generate and report key performance indicators.
  
• Prepare and approve SOPs and reports.
  
• Raise, investigate and close deviations, support change controls related to batch verification.
  
• Support periodic product reviews, complaints and adverse event reporting, and trending activities.
  
• Maintain and support compliance with quality systems such as ISO 13485 and local regulatory requirements.
  
• Communicate status and escalates quality issues to manufacturing sites, supply chain, external quality and regulatory stakeholders.
  
• Participate in audits and self-inspections and support responses to inspection findings.
  

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• Minimum education requirement of Leaving Certificate (Higher Level) or equivalent, including QQI Levels 3–5 or Junior Certificate. A degree in a relevant scientific discipline is desirable.
  
• Experience in quality review of batch records, deviations and test results within a regulated environment.
  
• Working knowledge of medical device quality requirements, Good Manufacturing Practice or similar standards.
  
• Experience with quality documentation, investigations, root cause analysis and corrective/preventive action processes.
  
• Strong communication skills with experience working across multi-disciplinary teams.
  
• Proficient with common office IT tools and comfortable learning quality management systems.
  

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• Familiarity with ISO 13485 and medical device regulatory requirements (for example MDR).
  
• Experience with electronic quality systems such as Veeva QMS, Veeva Vault or similar.
  
• Previous experience supporting regulatory inspections or presenting data to regulators.
  
• Knowledge of distribution and storage quality practices.
  
• Experience in batch release processes for products manufactured outside the region.
  
• Experience in manufacturing site operations, batch record review, quality data review and operational quality requirements.
  
• A detail‑focused approach with evidence of continuous improvement or process optimisation work. xcfaprz
  

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.

Closing Date for Applications – 24th April 2026 (COB)