Medical Device Audit Specialist (ISO 13485)

TÜV Rheinland Europe; United Kingdom; Hybrid; GBP 45,000 - 65,000; Full time

Benefits offered by this job

Hybrid work model

Annual bonus

Private medical care

Group life insurance

Pension scheme

Employee discounts

Salary sacrifice options

Diverse team

International environment

Casual dress code

Job summary

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

Candidates should hold a technical degree and have at least four years of relevant experience, with ISO 13485 knowledge and willingness to travel internationally.

Qualifications

• 4+ years of professional experience in medical device industry.
• Degree in IT, Biomedical Engineering, Biomechanics, Electronics, Electrical Engineering, or Automation.
• Knowledge of ISO 13485 quality management systems is desirable.

Responsibilities

• 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.

Skills

Interpersonal skills

Communication skills

Attention to detail

Teamwork

Education

IT

Biomedical Engineering

Biomechanics

Electronics

Electrical Engineering

Automation

Job description

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

Candidates should hold a technical degree and have at least four years of relevant experience, with ISO 13485 knowledge and willingness to travel internationally.