ISO 13485 Recruitment
At QAagency, we specialise in connecting organisations with skilled professionals experienced in implementing and managing ISO 13485 standards. ISO 13485 is the internationally recognised standard for Quality Management Systems (QMS) in the medical device industry, ensuring that organisations meet stringent regulatory requirements and deliver safe, effective products.
ISO 13485 plays a critical role in maintaining the safety and reliability of medical devices throughout their lifecycle, encompassing design, production, and distribution. Compliance with this standard demonstrates an organisation’s commitment to quality and regulatory adherence, fostering trust with clients, regulators, and end-users.
2025 QAagency Salary Survey
The demand for ISO 13485-certified professionals has seen a notable increase, reflecting the industry’s focus on stringent quality management and regulatory compliance. Our latest survey highlights several key trends shaping the UK market in 2025:
Average salary for ISO 13485 professionals is £45,000, with senior roles reaching up to £60,000.
The highest demand is in medical device manufacturing, driven by increased innovation and regulatory scrutiny.
39% of organisations implementing ISO 13485 have expanded their quality teams in the past year to meet growing compliance requirements.
In the Midlands and North West, average salaries are £40,000 and £42,500 respectively, reflecting the concentration of medical device companies in these regions.
Professionals with expertise in both ISO 13485 and ISO 14971 are securing salaries up to 10% higher than those with single-discipline experience.
At QAagency, we recruit for a range of ISO 13485-focused roles, including Regulatory Affairs Managers, Quality Assurance Engineers, ISO 13485 Auditors, Validation Specialists, and Compliance Managers. These professionals are responsible for developing and maintaining QMS tailored to medical device regulations, conducting internal audits to ensure compliance with ISO 13485 and regional standards, overseeing validation and verification processes to ensure product safety, and managing documentation and risk assessments throughout the product lifecycle.
We support organisations across various industries where ISO 13485 compliance is essential. In medical device manufacturing, professionals ensure consistent quality in design and production processes. In healthcare technology, they manage quality in software and devices used in medical environments. In pharmaceuticals, they oversee packaging and delivery systems for drug products. In biotechnology, they ensure regulatory compliance in the development of diagnostic tools and equipment.
Implementing ISO 13485
Organisations adopting ISO 13485 benefit from enhanced product quality, improved risk management, and increased market access. Professionals in these roles are often tasked with developing and maintaining QMS that comply with medical device regulations, conducting internal audits to ensure adherence to ISO 13485 and other relevant standards, overseeing validation and verification processes to guarantee product safety, and managing comprehensive documentation and risk assessments throughout the product lifecycle.
Recruitment Trends
The 2025 QAagency survey highlights key trends influencing ISO 13485 recruitment:
Regulatory changes: Stricter requirements, such as the EU Medical Device Regulation (MDR), are heightening the need for compliance expertise.
Advances in medical technology: Innovative devices require robust quality systems, creating opportunities for skilled professionals.
Global market expansion: Companies aiming to enter new markets are seeking ISO 13485-certified professionals to navigate diverse regulatory landscapes.
