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Biomedical Engineers

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Cirencester Gloucestershire, United Kingdom Corin Group Full time

Vigilance Coordinator required to work within our Global Vigilance team, based at our Global HQ in Cirencester, Gloucestershire 2-3 days a week on a hybrid full-time contract.
Do you have a mechanical or biomedical engineering degree, a great eye for detail, and a willingness to work within a global orthopedic medical device organization?

Corin is looking for a Vigilance Coordinator to join our high-performing team, working in a fast-paced, agile environment. You will be responsible for ensuring that all Regulatory and Quality Assurance requirements are routinely met with regards to the timely review, investigation, and reporting of product-related issues, the monitoring of trending information from a variety of sources, to pre-empt potential issues.

Corin is a medical device business with innovative robotically assisted platforms for joint replacement surgery. The day-to-day administration of all aspects of Complaints/Vigilance, including product complaints, on a site level at Corin UK and to always maintain compliance with the Quality Management System (QMS).
First point of contact for complaints and feedback received from Corin.
In charge of making initial case triage assessment of complaints and assessing initial risk and severity.
Prepare the assessment of the complaints reporting to the health authorities and the notified body within the appropriate timelines and report cases as applicable.
Transfer data into the appropriate e-QMS “Vigilance System” (as required).
Process and close the Complaints files.
Provide ad-hoc admin support to the team.
A Bachelor’s degree, master's, or PhD in Biomedical Engineering, Life Science, or a bachelor’s degree and related experience.
Excellent verbal and written communication skills in English
Basic understanding of technology or science
Good knowledge of Office Tools (Word, Excel, Internet, PowerPoint) & ERP (SAGE / eQMS).
An understanding of adverse event reporting and be proficient with MS Word and Excel.
Knowledge of the Medical Devices Directives (MDD) and future Medical Device Regulation as applicable to role is desired