BSI Group

Clinical Evaluation Specialist - Active Implantable Medical Devices

BSI Group
22 May 2019
21 Jun 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 Active Implantable Medical Devices (AIMD) 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.

You'll be working with a variety of medical device professionals, such as our Technical Specialist to determine the clinical impact of design changes and determine the level of clinical assessment required. You'll be responsible for ensuring that the clinical aspects of Design Dossier Reviews and Technical File Reviews are completed on time. You'll also work with our Internal Clinicians to ensure that the relevant External Clinical Experts and Clinical Statisticians are engaged in the clinical assessment process as well as ensuring that the clinical requirements of the Active Implantable Medical Devices Directive and Medical Device Regulations are being met.

Medical Devices | Clinical | AIMD | Clinician