Regulatory & Quality Lead, Medical Devices

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

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.