Description
Successful London based medical device company has recently restructured and are now looking for a Complaints & Vigilance Administrator to keep this Companies compliance up to speed.The Complaints & Vigilance Administrator is responsible for ensuring all complaints received are logged and processed in a uniform and timely manner. Obtaining all information required in order to enable a thorough investigation to be carried out by communicating with internal and external customers.
Main Responsibilities include;
- Reviewing all complaints for regulatory reportability and preparing and submitting reports to the FDA/National Competent Authorities as required.
- Providing feedback to customers following completion of complaint investigations.
- Assisting with complaint trending and data preparation for monthly complaint meetings and annual management reviews.
- Supporting the QA/RA team during third party audits of the business by providing reports, complaint records and vigilance records as required.
- Main point of contact for all customer complaints in accordance with procedures
- Creation and maintenance of complaint records
- Input of complaints onto the complaint database and trending activities
- Following up with internal and external customers to obtain further information to assist the Complaints & Vigilance Engineer with their investigation
- Escalate issues to the Complaints & EC Vigilance Manager when they arise
- Ensuring that all complaint processing is carried out in line with the procedures
- Creation and submission of vigilance reports to appropriate regulatory bodies in a timely manner
- Assisting with Health Hazard Evaluations and Field Safety Corrective Actions/Recalls, when required
- Any other tasks or duties that are deemed appropriate by your line manager.
Essential Requirements;
- Educated to GCSE Level or equivalent
- Proven experience of handling customer complaints
- Experience of working in a regulated industry would be desirable
- Must be able to effectively communicate verbally and in writing with all levels of SIW staff, clinicians and other external customers, Notified Bodies and Competent Authorities.
- Excellent Microsoft Excel, Word and Outlook skills
- Ability to use initiative and work with minimum supervision
- Data analysis experience would be desirable
- Understanding of the Medical Devices Directive 93/42/EEC, ISO 13485, and FDA 21 CFR 803, 806 and 820 is desirable.
My client is looking to pay around £30,000 for this position. If you believe you have the required experience then please send me your CV and I will be in touch shortly.