Vigilance Coordinator

Do you have a mechanical or biomedical engineering degree, a great eye for detail and a willingness to work within a global orthopaedic medical device organisation? Corin are 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. We offer a unique combination of clinically proven hip & knee solutions and world leading technologies. Our Apollo & OPS systems utilize intelligent instrumentation to give surgeons the ability to perform patient-specific procedures with high accuracy, with more consistent results and improved recovery rates. The key responsibilities of the Vigilance Coordinator are to:

• 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 to the Quality Management System (QMS).
• First point of contact for complaints and feedback received into Corin.
• In charge of making initial case triage assessment of complaints and assessing initial risk and severity.
• Evaluate that information received is sufficiently detailed and request and obtain additional details where incomplete.
• 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 of data into appropriate e-QMS "Vigilance System" (as required).
• Coordinate Root Cause Investigation activities on a site level (as required).
• Support customer response activities in collaboration with Vigilance Manager or Team Leader.
• Process and close the Complaints files.
• Provide weekly reports to Manager/Team Leader.
• Assist with returned item investigations.
• Maintain hard and soft copy case files.
• Process feedback and follow-up activities.
• Provide ad-hoc admin support to the team.
• Support continuous process improvement.
  
  A Bachelor's degree in 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
• High standard of attention to detail.
• Good verbal and written communication skills.
• Ability to work on own initiative.
• Team player.
• Good time management skills, ability to multi-task and deliver activities to timelines
• Professional approach to work.