Medical Device Lead Auditor

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