Head of Regulatory and Quality Affairs

GBUK Group; Selby; Hybrid; GBP 90,000 - 130,000; Full time

Benefits offered by this job

Hybrid working

Global medical device exposure

Job summary

GBUK is seeking a Head of Regulatory Affairs and Quality Affairs to lead the Quality Management System across our UK and Ireland sites. The role focuses on ISO 13485 and ISO 9001, regulatory oversight of suppliers, labeling, and field activities, and preparing for external audits and inspections.

You will drive risk-based quality controls, manage audits and CAPA, and translate regulatory requirements into practical, efficient processes to support continued growth.

Qualifications

• Experience with ISO 13485 and ISO 9001 Quality Management Systems.
• Proven ability to lead audits, CAPA and document control processes.
• Strong understanding of EU medical device legislation and regulatory inspections.
• Ability to translate regulatory requirements into practical processes.

Responsibilities

• Lead and continually improve the Quality Management System across sites.
• Maintain compliance with ISO 13485 and ISO 9001 requirements.
• Oversee internal audits, non-conformances, CAPA, deviations and change control.
• Manage quality documentation and document control systems.
• Provide regulatory input for new products, suppliers and changes.
• Coordinate audits, certifications and regulatory inspections.

Skills

Regulatory leadership

Quality management

ISO 13485 & ISO 9001

Audits & CAPA

Risk management

Regulatory affairs liaison

Education

Quality/Regulatory professional qualification

Job description

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.

About you:

We’re looking for an experienced Quality and Regulatory professional with a strong background in the medical device or healthcare sector and demonstrable experience working within a regulated environment.

You’ll need:

• Practical experience working with ISO 13485 and/or ISO 9001 Quality Management Systems.
• Experience managing audits, non‑conformances, CAPA and document control.
• A strong understanding of risk‑based quality management.
• Experience working with external suppliers and/or outsourced service providers.
• Experience dealing with regulatory authorities, third‑party audits and regulatory inspections.
• Knowledge of applicable EU medical device legislation and Irish/EU regulatory requirements.
• The ability to translate regulatory and quality requirements into practical, proportionate operational processes.
• Strong organisational, analytical and communication skills.
• The confidence and independence to take ownership of the Quality and Regulatory function and provide constructive challenge where required.
• A relevant professional qualification or significant experience in Quality, Regulatory Affairs, Compliance or a related discipline is expected.
• Formal qualifications in quality management, regulatory affairs, pharmacy, science, engineering or a related discipline would be desirable.
• Experience with medicinal product distribution and GDP principles, outsourced warehousing/logistics, field service, technical service or OEM equipment support would be advantageous.

Why GBUK?

GBUK is an ambitious and growing medical device business, and this role comes at an important point in our continued development.

You’ll have the opportunity to shape and strengthen the way Quality and Regulatory operates as the business grows, working closely with senior leadership and teams across the organisation.

This isn’t simply a role focused on maintaining compliance. We’re looking for someone who can bring expertise, challenge and practical thinking to the business, helping us maintain high standards while ensuring our processes remain proportionate, effective and capable of supporting future growth.

If you’re looking for a role where you can take ownership, make a genuine impact and help shape the future of Quality and Regulatory within a growing organisation, we’d like to hear from you.

This role can be based in either UK (our Head Office in Selby, North Yorkshire, with a hybrid working arrangement), or in Ireland (our site in Dublin).