IMSM

Auditor

• Conduct consultancy assignments in accordance with agreed contractual terms
• Prepare and deliver presentations and assessment reports that clearly communicate findings and decisions to clients
• Provide clear actionable recommendations for addressing any identified non-conformities or areas for improvement
• Ensure accurate and timely updates to client records and internal systems supporting data integrity and compliance
• Maintain and continually develop your technical knowledge and expertise in management systems and relevant standards

ISO Lead Auditor, ISO Consultant

• Deliver consultancy and audit assignments in line with agreed contractual terms, specifically for ISO 17025 laboratory management systems.
• Prepare and deliver presentations and assessment reports that clearly communicate findings and decisions to clients
• Provide clear, actionable recommendations for addressing any identified non-conformities or areas for improvement
• Ensure accurate and timely updates to client records and internal systems, supporting data integrity and compliance
• Maintain and continually develop your technical knowledge and expertise in management systems and relevant standards
• Stay up to date with developments in ISO 17025 and laboratory best practices

Lead Auditor, ISO 17025

Consultant

• Provide strategic guidance on FDA regulatory requirements, including submissions, compliance, and inspections
• Lead or support FDA submissions (e.g., 510(k), cosmetic product compliance, facility registrations)
• Develop, implement, and maintain Quality Management Systems (QMS) compliant with ISO 13485 and ISO 22716
• Conduct gap analyses and internal audits to assess compliance readiness
• Support preparation for FDA inspections and notified body audits
• Review and author SOPs, technical documentation, and quality records
• Advise on risk management processes and product lifecycle compliance
• Ensure alignment between US FDA regulations and international standards
• Train internal teams on regulatory requirements and quality standards
• Liaise with regulatory authorities and external stakeholders as needed

ISO Lead Auditor, ISO Consultant

Lead Auditor, ISO 17025

FDA Consultant, ISO 13485, ISO 22716 Experience

ISO Lead Auditor, ISO Consultant