Quality Consultant

Clinical & Quality Consultant - Vigilance & Lead Auditor

Maclivaro are working with a UK-based medical device company seeking an experienced Clinical & Quality Consultant to undertake an independent review of their vigilance processes, clinical adverse event reporting and investigation procedures.

Fully Remote UK Medical Device Company Contract

This is a specialist contract opportunity for an experienced Certified Lead Auditor with strong, hands on experience in medical device vigilance and the investigation and reporting of clinical adverse events.

The consultant will be expected to work completely independently, conducting a deep dive into the company's existing processes and procedures, identifying any gaps or areas of concern and assessing whether vigilance events are being identified, investigated, documented and reported correctly.

The Role

The initial project will focus specifically on the company's vigilance process, with particular emphasis on clinical adverse events.

You will independently assess the end-to-end process, including:

• How adverse events are identified and assessed
• Whether events are being classified and investigated appropriately
• Whether the correct information is being captured and documented
• Whether events are being reported correctly and within the appropriate requirements
• The quality and robustness of investigation processes
• Whether procedures are being followed consistently
• Whether the existing processes and procedures are sufficiently robust and compliant
• Identification of any gaps, inconsistencies, risks or potential compliance issues
• Providing clear recommendations for improvement where required

This will require someone who is comfortable going deep into the detail, reviewing documentation and individual cases, challenging existing processes where appropriate and forming an independent professional assessment.

Key Responsibilities

• Conduct a fully independent review/audit of the company's vigilance processes
• Deep dive into existing processes, procedures, SOPs and supporting documentation
• Review clinical adverse event cases and associated investigations
• Assess whether events have been appropriately identified, assessed, investigated and reported
• Identify any potential under reporting, over reporting, incorrect classification or procedural gaps
• Highlight areas of risk, non compliance or weakness
• Assess whether current procedures are being followed correctly and consistently
• Review the effectiveness of the overall vigilance process
• Provide an objective assessment of findings
• Clearly document findings, observations and recommendations
• Work independently without requiring significant direction from the client

About You

We are looking for someone with genuine hands on vigilance experience within the medical device industry.

Essential experience:

• Extensive medical device industry experience
• Certified Lead Auditor
• Proven experience auditing quality systems and processes
• Hands on experience with medical device vigilance processes
• Strong experience with clinical adverse event investigations
• Experience assessing whether adverse events have been appropriately reported
• Strong understanding of medical device post market surveillance and vigilance requirements
• Experience reviewing SOPs, procedures, records and individual cases in depth
• Able to identify gaps, inconsistencies and potential compliance issues
• Comfortable providing an independent and objective assessment
• Able to work completely autonomously
• Strong written and verbal communication skills

We are particularly interested in candidates who have previously undertaken independent vigilance audits, investigations, remediation or quality system reviews and can demonstrate that they have personally worked through the detail of vigilance cases and reporting decisions.

Contract Location: Fully Remote - UK Duration: Contract Start: ASAP Sector: Medical Devices Focus: Vigilance Clinical Adverse Events Investigation Reporting Quality Auditing Working Style: Completely Independent

This is an excellent opportunity for a senior Clinical / Quality Consultant and Certified Lead Auditor to undertake a focused, high value project within a medical device organisation, with the potential for further consultancy work following the initial engagement.

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