Remote Independent Vigilance & Quality Lead Auditor

Consult; United Kingdom; À distance; GBP 90 000 - 150 000; Plein temps

Résumé du poste

Maclivaro is seeking a Clinical & Quality Consultant with vigilance and lead auditing expertise for a UK medical device client. The role requires an independent, hands-on review of vigilance processes, adverse event investigations and reporting to identify gaps and ensure compliance.

You will conduct a deep-dive audit of SOPs, records and investigations, assess classification and reporting accuracy, and provide clear recommendations.

Qualifications

• Extensive medical device industry experience required.
• Certified Lead Auditor with proven auditing of quality systems.
• Hands-on vigilance processes and clinical adverse event investigations.
• Experience assessing adverse event reporting and post-market surveillance.
• Ability to identify gaps, non‑compliance and provide actionable remediation.

Responsabilités

• Conduct a fully independent review/audit of the company's vigilance processes.
• Deep dive into SOPs, procedures and supporting documentation.
• Review clinical adverse event cases and investigations.
• Assess whether events are identified, assessed, investigated and reported correctly.
• Identify potential under- or over-reporting and procedural gaps.
• Highlight risks, non-compliance or weaknesses and provide recommendations.
• Work independently with minimal direction and document findings clearly.

Connaissances

Medical device experience

Lead Auditor certification

Quality systems auditing

Vigilance processes

Clinical adverse events

Adverse event reporting

Post-market surveillance

SOP review

Independent assessment

Autonomous working

Strong communication

Description du poste

Maclivaro is seeking a Clinical & Quality Consultant with vigilance and lead auditing expertise for a UK medical device client. The role requires an independent, hands-on review of vigilance processes, adverse event investigations and reporting to identify gaps and ensure compliance.

You will conduct a deep-dive audit of SOPs, records and investigations, assess classification and reporting accuracy, and provide clear recommendations.