Biomedical Engineers
3 weeks ago
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.
Want to apply Read all the information about this position below, then hit the apply button.
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. 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, 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 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.
- Evaluate that the 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 data into the 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 the 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.
The ideal Vigilance Co-ordinator will have the following skills and competencies:
- 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
- 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.
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Cirencester, Gloucestershire, United Kingdom Corin Group Full timeJob Description 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?...
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Cirencester, Gloucestershire, United Kingdom Corin Group Full timeVigilance 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...
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Cirencester, United Kingdom Corin Group Full timeVigilance 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...
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Cirencester, United Kingdom Corin Group Full timeVigilance 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...
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Cirencester, United Kingdom Corin Group Full timeVigilance 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...
