Complaints Manager

Job Title: Complaints Manager

Job Type: Permanent

Location: Oxford, UK (travel up to 20%)

Position Summary:

A world-leading medical technology company developing innovative solutions are seeking a motivated Complaints Manager to join the team as part of its global expansion. This is an opportunity to work in an innovative, fast-paced global medical device organisation committed to improving patient outcomes.

The position of Complaints Manager will ensure compliance of the Complaints System to internal requirements and domestic and international regulations. This includes the management of regulatory activities related to complaints reporting, planning and executing field corrective actions, as well as the quality systems processes and procedures, training materials, and controls that support execution of medical device reporting and field corrective actions in conformance to established agency regulations.

Key Responsibilities:

• Establish a forward-thinking vision for complaint handling, aligning team objectives with overall company strategy and industry best practice
• Leading staff responsible for initiating complaints and ensuring all required information is added to the complaints file in an accurate and timely manner.
• Communicating with customers and field representatives in a professional manner to gather additional complaint information as warranted.
• Supporting service and repair events including evaluation of intake information, review of repair activities to assess whether a complaint is warranted, and facilitation of device returns.
• Collaboration and support globally on global projects as needed.
• Leading continuous improvements and ongoing compliance of the Complaints, Post Market Surveillance, Regulatory Reporting and Risk Management Systems.
• Supporting internal and external audits.
• Ensuring assigned complaint metrics are achieved (e.g., achieve target times for complaint reporting or complaint completion).
• Assisting with training staff to ensure compliance to Complaints/Post Market Surveillance requirements.
• Preparing reports on complaint trending, complaint metrics, post market surveillance activities, Periodic Safety Reports etc.
• Ensuring Adverse Event Reporting regulatory guidance documents are available prior to product launch within all jurisdictions and applicable Post Market Surveillance activities are captured.
• Completing reportability assessments and routing for approvals in a timely manner.
• Submitting adverse event/vigilance reports to TGA, MHRA, FDA, Health Canada, notified bodies, and competent authorities as appropriate.
• Ensuring complaints are prioritized based on patient, product, and compliance risk

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, Quality Management, or related field (Master’s preferred).
• Minimum 5 years of experience in quality assurance, complaints handling.
• In-depth knowledge of FDA, ISO 13485, and EU MDR regulations regarding complaint handling.
• Experience with communication to local authorities (e.g., FDA, Health Canada) preferred.
• CAPA process knowledge preferred.
• Internal auditor training a plus
• Working knowledge of FDA processes for medical device compliance
• Knowledge of EU MDD / MDR, MDSAP, CMDR, PMDA/PAL, APAC Country requirements, LATAM

Please reach out to emily.james@skillsalliance.com for further details.