ISO 13485 Recruitment
ISO 13485 is the international quality management standard for medical devices, setting strict requirements around regulatory compliance, product safety and traceability. QAagency specialises in recruiting professionals with ISO 13485 experience, supporting organisations operating within highly regulated medical device and life sciences environments across the UK.
ISO 13485 roles are typically found within medical device manufacturing, diagnostics, combination products and regulated healthcare technology businesses. These positions are usually site-based due to their close involvement with production, validation and regulatory activity, although some roles offer hybrid working where system ownership or supplier quality responsibilities allow. Accuracy, documentation discipline and regulatory awareness are critical, as quality decisions directly affect product release and patient safety.
Professionals working within ISO 13485 environments commonly report into a Quality Manager, Regulatory Affairs Manager or Head of Quality. Responsibilities often include maintaining the quality management system, managing audits, overseeing change control and ensuring compliance with UKCA, CE marking and relevant regulatory frameworks.
Roles we recruit for within ISO 13485 environments
We recruit across a range of ISO 13485-focused roles, including QA Officers and Quality Technicians supporting documentation and in-process compliance, Quality Engineers managing CAPA, validation and risk management activities and Senior Quality Managers or Heads of Quality responsible for regulatory readiness and inspection performance.
Many of these roles also involve close collaboration with regulatory affairs, supplier quality and manufacturing teams, particularly where products are supplied into international markets.
2026 salary insight: ISO 13485 roles
Based on QAagency 2026 salary benchmarking, average UK salaries for ISO 13485-focused roles are:
QA Officer or Quality Technician (0–2 years experience): £33,100
Quality Engineer (3–5 years experience): £44,600
Senior Quality Engineer (5–10 years experience): £55,800
Quality Manager or Head of Quality: £72,400
Salary progression within ISO 13485 roles is strongly influenced by regulatory exposure, inspection experience and responsibility for validation, risk management and authority-facing activity. Professionals with experience supporting MHRA inspections or managing regulated product release typically sit at the higher end of the market.
Data based on QAagency 2026 salary benchmarking.
Market and hiring trends in ISO 13485 recruitment
Demand for ISO 13485 professionals has remained strong through 2025 and into 2026, driven by ongoing regulatory change, increased scrutiny of medical devices and growth in health technology and diagnostics. Many organisations have strengthened quality teams to support compliance, scalability and inspection readiness.
Year on year salary growth from 2025 to 2026 has typically ranged between 4.9% and 5.6%, with the strongest increases seen at senior and management level. Over the past five years, salaries for ISO 13485-aligned roles have increased by approximately 23%, reflecting heightened regulatory pressure and limited candidate availability.
Employers are increasingly seeking candidates who can operate confidently across quality systems, validation and risk management rather than siloed responsibilities. Experience across both quality assurance and regulatory interaction continues to attract a clear salary premium.
Location and salary variation
London and the South East continue to offer the highest salaries for ISO 13485 roles, particularly within regulated manufacturing and corporate quality functions. However, strong medical device hubs in the Midlands, South West and East of England have seen steady salary growth, narrowing regional gaps.
For ISO 13485 roles, salary is increasingly driven by regulatory scope, inspection exposure and product complexity rather than location alone. Candidates with authority-facing experience are consistently able to command higher salaries across all regions.
