Job Title: Medical Device Auditor Location: Remote, UK Based Travel: Will be required Our client is looking for a Medical Device Auditor to plan and conduct professional management system audits in accordance to the company’s procedures. Key Responsibilities: • Conduct audits at client sites or remotely to meet regulatory and stakeholder requirements. • Complete all chargeable work within budget and timelines to ensure customer satisfaction. • Manage specific projects related to medical device procedures, systems, and documentation. • Provide accurate and timely reporting for planning and operational management. • Oversee auditing teams to enhance client satisfaction and ensure compliance. • Manage personal schedule to meet chargeability targets. • Provide technical support and training to staff both in the UK and internationally. • Support business development efforts, including sales visits and event participation. • Conduct internal audits to ensure compliance with standards. • Maintain and update personal training records and certifications. Qualifications & Experience: Essential: • Proven experience in the healthcare or medical device industry, with experience in quality management. • Strong knowledge of medical device regulations: EU MDD 93/42/EEC, MDR 2017/745, IVDR 2017/746, UK MDR 2002, ISO 13485, MDSAP. • Experience in regulatory affairs, quality management, or clinical evaluations. • Competent in using MS Office and large databases. • Full UK driving license. • University degree or equivalent in relevant sciences (e.g., Medicine, Pharmacy, Biochemistry, Biomedical Engineering). Desirable: • Registered IRCA lead auditor or similar certification. • Experience in reviewing technical documentation and audit packs