Overview

Quality & Regulatory (Manager or Senior Engineer) – Location: Northern Ireland Hybrid, UK remote, depending on candidate expertise.

About the Role

My client is searching for a Quality and Regulatory engineer. Depending on the experience of the successful candidate, this may be:

Quality and Regulatory Manager – leading on ISO 27001 and data protection compliance, with responsibility for our ISO 13485-certified QMS, acting as Management Representative.

Senior Quality & Regulatory Engineer (minimum 2 years exp) – leading on ISO 27001 and data protection compliance, managing and maintaining our QMS.

Requirements

Must Have:

• Proven software quality experience in a regulated environment (medical devices, drug development, Biomedical Software or similar).
• Direct working knowledge and experience of ISO 27001.
• Practical experience with EU & UK GDPR / Data Protection Act.
• Internal auditing experience.
• Detail-oriented, adaptable, collaborative, and self-motivated.
• Right to work in the UK (Preference for candidates in Northern Ireland, but open to UK).

Additional Expertise (Manager-level candidates):

• Experience maintaining an ISO 13485-certified QMS (with EN 62304, ISO 14971 standards).
• Knowledge/awareness of the AI Act and EU Cyber Resilience Act.
• US data protection legislation experience.
• Familiarity with cloud infrastructure (e.g. AWS).
• EU IVDR/MDR and UK Medical Device Regulation experience.

Contract type: Non-permanent (Maternity Leave Cover) - could be extended to fulltime perm role.