Medical Device Assessor

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

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