BSI Group

Clinical Evaluation Specialist - Vascular Devices

BSI Group
29 Apr 2019
29 May 2019
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Do you have experience within the clinical field?  Have you worked with Medical Devices previously?  Would you like to work with cutting edge innovation and state of the art technologies?

Due to continuing strategic growth within our Medical Devices business, we currently have vacancies for Clinical Evaluation Specialists. This is an excellent opportunity to join a leading Notified Body, driving up the standard of safety and performance of Medical Devices for patients across Europe, and to be involved in the evaluation of cutting edge innovation and state of the art technologies.

This is a home based role which could be carried out remotely in the UK, France, Germany, Spain, The Netherlands, or Italy.

This role offers real diversity and variety carrying out detailed assessments of clinical data to ensure that  Vascular Devices meet the safety and performance requirements of the regulations including; First in man protocols and test results, Animal test protocols and results, Clinical strategy documents, Clinical investigation protocol and results, Clinical evaluation reports, Instructions for use (intended use, contraindications, warnings and precautions), Post market clinical follow-up (PMCF) protocol and results, Post market surveillance data including vigilance reports, Risk management documentation, Periodic summary update reports (PSUR), and summery of Safety and Clinical Performance (SSCP) reports.

In this role you'll be compiling Clinical Evaluation Assessment Reports (CEAR’s), managing the submission of CEAR’s and supporting documentation to the EU Commission for clinical evaluation consultation.

To be successful in this role you'll need to demonstrate a thorough knowledge of the design, development and implementation of clinical trials, a working knowledge of ISO 14155 Clinical investigation for medical devices for human subjects – Good clinical practice, a working knowledge of MEDDEV 2.7/1, Rev 4, CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC.

You'll show a proven track record of Risk management and in particular the assessment of clinical data to support a risk / benefit argument as well as involvement in clinical trials, including providing clinical support to physicians and surgeons and a BSc, MSC, or PhD degree in a discipline relevant to medical device manufacture and use (e.g. engineering, medical, nursing etc.), or equivalent qualification.

The role requires you to have extensive experience with one or more of the following Vascular devices:

  • stents and stent delivery systems
  • percutaneous heart valves
  • devices to treat abdominal aortic aneurysms ablation
  • electrophysiology catheters
  • neurovascular experience (embolic coils, neurovascular stents and related accessories)
  • basic experience with other cardiovascular devices such as balloon catheters, PICC or CVC catheters, guide wires, introducers, closure devices and related accessories.

What we offer:

We offer a highly competitive starting salary plus 10% bonus.  BSI also offers employees a wide range of flexible benefits that you can tailor to suit your life-style.

We pride ourselves on setting the industry benchmark and invest significantly in our teams to ensure that our people have the best possible opportunity to deliver an excellent service and progress their careers.  As the successful candidate, you will embark on a comprehensive induction into the role and will be supported in a continuous professional development programme.