Medical Device Assessor

TÜV Rheinland Europe; United Kingdom; Hybrid; GBP 55,000 - 75,000; Full time

Benefits offered by this job

Hybrid work model

Annual bonus subject to performance

Private medical care

Group life insurance

Workplace pension scheme

Employee discounts

Salary sacrifice options

International environment

Job summary

TÜV Rheinland Europe is seeking a Medical Device Assessor/Auditor with a strong background in medical device design, manufacture, testing, or quality control. The role involves planning audits at client sites, reviewing documentation, and ensuring regulatory compliance.

You will work in a hybrid environment with international travel and opportunities to contribute to service development. The ideal candidate has 4+ years in the medical device sector and familiar with ISO 13485 and regulatory

Qualifications

• Bachelor’s or higher degree in IT or related technical/scientific field.
• Experience in medical device industry with design, manufacture, testing, or quality control (4+ years).
• Knowledge of ISO 13485 and medical device regulations is desirable.

Responsibilities

• Plan and conduct audits at client sites.
• Prepare post-audit documentation and reports.
• Maintain professional qualifications and certifications.
• Review clients’ technical documentation for medical devices against regulatory requirements.
• Build and maintain client relationships; participate in growth projects.
• Assess Quality Management Systems for ISO 13485 compliance.
• Identify non-conformities and provide evidence-based feedback.

Skills

Interpersonal skills

Communication skills

Teamwork

Detail-oriented

Self-motivated

Proactive

Travel willingness

Education

Engineering degree (IT / Biomedical / Electronics)

Job description

We are looking for a Medical Device Assessor / Auditor with a background in medical device designing manufacturing, or quality control. Candidates must have at least 4 years’ professional experience in one or more of these areas, of which at least 2 years must be directly related to the design, manufacture, testing, quality control, or use of the medical device or technology being assessed.

Job Description

• Planning and conducting audits at client sites.
• Preparing comprehensive post-audit documentation and reports
• Maintaining and developing professional qualifications and certifications.
• Acting as Product Specialist, reviewing clients’ technical documentation for medical devices in accordance with applicable regulatory requirements, standards, and internal procedures.
• Building and maintaining positive, long-term relationships with clients.
• Contributing to the development of new services and participating in strategic growth projects.
• Perform detailed assessments of Quality Management Systems to ensure full compliance with ISO 13485 requirements.
• Identify and document non-conformities while providing clear, evidence-based feedback to clients.
• Act as a subject matter expert during the audit process, ensuring all regulatory requirements for medical devices are met.

What we expect of you?

• Higher education degree in IT, Biomedical Engineering, Biomechanics, Electronics, Electrical Engineering, Automation, or a related technical/scientific field.
• At least 4 years of professional experience gained in the medical device industry, particularly in the design, manufacture, testing, quality control, or use of medical devices or related technologies.
• Practical understanding of medical device development, production, testing, quality control, or clinical/user application.
• Knowledge of Quality Management Systems for medical devices, particularly ISO 13485:2016, is desirable.
• Familiarity with applicable medical device regulations, including UK MDR, UK IVDD, EU MDR and EU IVDR, is desirable but can be further developed internally.
• Strong interpersonal and communication skills, with the ability to build professional relationships with clients and colleagues.
• Self-motivated, proactive, and detail-oriented.
• Ability to work effectively within a team.
• Willingness to travel frequently, including international business trips.

What we can offer you?

• Hybrid work model and flexible working hours
• Annual bonus subject to company and individual performance
• A package of benefits: private medical care, group life insurance, workplace pension scheme, employee discounts, Salary sacrifice options
• Work in a friendly, diverse and high-qualified team with positive and cooperative working atmosphere
• International environment and daily usage of foreign languages
• Direct communication and no formal dress code