Medical Device Assessor

Products

In the Products business unit at TÜV Rheinland, we are looking for talents who want to stand with us at the forefront of safety, quality, and innovation. Our goal is to make products safe and compliant with standards in international markets – from consumer goods to highly complex medical devices. In doing so, we support companies in complying with national and international standards.

Our focus is on the challenges of digitalization, sustainability, and global trade requirements. Whether smart technologies, sustainable materials, or the safety of connected products – we actively shape the future of product safety.

• Softlines:
  Testing, inspection, and certification services for textiles, clothing, footwear, leather goods, and other consumer products.
• Hardlines:
  Safety and quality testing for household goods, toys, furniture, sports equipment, tools, and DIY products.
• Electrical:
  Testing and certification of electrical and electronic products, from household appliances to industrial control systems.
• Solar & Commercial:
  Quality assurance and certification of photovoltaic modules, inverters, and commercial technical installations.
• Medical:
  Comprehensive testing and certification for medical devices, from diagnostic equipment to implants, including regulatory consulting.

Seeking a Medical Device Auditor to conduct client audits, assess Quality Management Systems, and ensure compliance with UK and EU regulatory standards. The role involves reviewing technical documentation, identifying non-conformities, and building strong client relationships.

• Higher education degree in IT, Biomedical Engineering, Biomechanics, Electronics, Electrical Engineering, Automation, or a related field.
• At least 4 years of professional experience in the development, maintenance, or management of medical devices.
• Strong knowledge of Quality Management Systems (QMS) for medical devices and familiarity with regulations (UK MDR [MHRA], UK IVDD [MHRA], ISO 13485:2016 [UKAS], EU MDR and EU IVDR) is highly desirable.
• Strong interpersonal and communication skills with the ability to build professional relationships.
• Self‑motivated, proactive, and detail‑oriented.
• Ability to work effectively within a team.
• Willingness to travel frequently, including international business trips.

• 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
• Well being Support
• Work in a friendly, diverse and highly qualified team with positive and cooperative working atmosphere
• International environment and daily usage of foreign languages
• Real development opportunities
• Direct communication and no formal dress code
• Employee referral program

• 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.