Head of Regulatory Affairs and Quality Affairs

A key leadership opportunity within a growing medical device business.

This role can be based in UK or Ireland (North Yorkshire or Dublin- hybrid working offered).

GBUK is continuing to grow, and as our organisation evolves, we’re strengthening our Quality and Regulatory capability with the appointment of an experienced Head of Regulatory Affairs and Quality Affairs.

This is a key role within the business, with responsibility for the leadership, maintenance and continual improvement of our Quality Management Systems, while providing senior quality and regulatory oversight across our operations, sites and outsourced activities.

We’re looking for someone who can combine strong technical and regulatory expertise with a practical, hands-on approach. You will be someone who takes ownership, challenges constructively and translates regulatory requirements into processes that work effectively in the real world.

The opportunity:

As Head of Regulatory and Quality Affairs, you’ll lead the maintenance and continual improvement of our Quality Management Systems across both sites, with a particular focus on ISO 13485 and ISO 9001.

You’ll provide quality and regulatory oversight across our operations, including internal and outsourced warehousing and distribution, suppliers and service providers, product and labelling controls, and OEM equipment servicing and field activities.

You’ll also play a central role in ensuring the business is prepared for external audits, certification activities and regulatory inspections, while helping to embed a consistent culture of quality and compliance across the organisation.

What you’ll be responsible for:

• Own and continually improve the company’s Quality Management System across both sites.
• Maintain compliance with ISO 13485 and ISO 9001 requirements.
• Lead internal audits, non-conformances, CAPA, deviations, change control and quality improvement activity.
• Monitor quality KPIs, objectives and trends, providing clear reporting to senior management.
• Maintain robust quality documentation and document control processes.
• Provide internal leadership on regulatory and compliance matters, including applicable Irish and EU medical device and Economic Operator requirements.
• Provide regulatory input into new products, suppliers, customers, services and operational changes.
• Oversee quality and regulatory controls relating to product labelling, verification and over-labelling.
• Provide quality oversight of internal and outsourced warehousing and logistics operations.
• Lead the qualification and ongoing monitoring of key suppliers and third-party service providers.
• Ensure appropriate controls are in place for product storage, traceability, returns, recalls, complaints and distribution.
• Provide quality and regulatory oversight of OEM equipment servicing and field activities.
• Plan and coordinate internal and external audits, ISO certification activities and regulatory inspections.
• Ensure audit findings, CAPAs and other actions are investigated, managed and effectively closed.
• Develop and maintain risk-based approaches to quality and regulatory controls.
• Support the development of quality and regulatory competence across the wider organisation.
• Identify opportunities to improve quality, compliance and operational efficiency.