Complaints Resolution Specialist
6 days ago
Job Title: Complaints Resolution Specialist
Location: Oxford, UK (with up to 20% travel)
Overview:
A pioneering medical technology company is seeking a motivated Complaints Resolution Specialist to join its global expansion team. This exciting opportunity allows you to work in a fast-paced, innovative environment committed to enhancing patient outcomes.
The Complaints Resolution Specialist will ensure compliance with internal requirements and domestic/international regulations regarding complaint handling. Key responsibilities include managing regulatory activities related to complaints reporting, field corrective actions, quality systems processes, training materials, and controls supporting medical device reporting and field corrective actions in accordance with established agency regulations.
Main Responsibilities:
- Establish a forward-thinking vision for complaint handling, aligning team objectives with overall company strategy and industry best practice.
- Lead staff responsible for initiating complaints and ensuring all required information is added to the complaints file in an accurate and timely manner.
- Communicate professionally with customers and field representatives to gather additional complaint information as warranted.
- Support 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.
- Collaborate globally on projects as needed.
- Lead continuous improvements and ongoing compliance of the Complaints, Post Market Surveillance, Regulatory Reporting, and Risk Management Systems.
- Support internal and external audits.
- Evaluate assigned complaint metrics, such as achieving target times for complaint reporting or completion.
- Assist with staff training to ensure compliance with Complaints/Post Market Surveillance requirements.
- Prepare reports on complaint trending, metrics, post market surveillance activities, Periodic Safety Reports, etc.
- Ensure regulatory guidance documents are available prior to product launch in all jurisdictions and capture applicable Post Market Surveillance activities.
- Complete reportability assessments and route for approvals in a timely manner.
- Submit adverse event/vigilance reports to relevant authorities as necessary.
- Prioritize complaints based on patient, product, and compliance risk.
About the Role:
This challenging role requires a highly skilled individual who can drive effective complaint handling practices, ensuring compliance with regulatory requirements and fostering a culture of excellence within the organization.
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.
- Familiarity with EU MDD / MDR, MDSAP, CMDR, PMDA/PAL, APAC Country requirements, LATAM.
Estimated Salary Range: £60,000 - £80,000 per annum, depending on qualifications and experience.
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