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 home-based 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 role offers real diversity and variety carrying out detailed assessments of clinical data to ensure that orthopaedic and spinal implants 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 Summary 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 will 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.|
This home-based position is full-time, salaried, and involves up to 25% travel by car and plane for client meetings, trainings, and team meetings. &
Only candidates who are a qualified doctor of medicine (MD) or nurse will be considered.
Do you believe the world deserves excellence?
BSI (British Standards Institution) has over 81,000 clients in 180 countries, and is an organization whose standards inspire excellence across the globe. BSI Medical Devices Notified Body provides rigorous CE and ISO 13485 certification to manufacturers globally. The team apply their knowledge to 3rd party conformity assessment of all types of medical devices; active devices, active implantable devices, in vitro diagnostic devices, orthopaedic and dental devices, vascular devices, wound care devices and many others. The team has doubled in size over the past eight years, demonstrating the company’s desire to succeed and deliver world beating results. There are exciting opportunities for further growth of the Medical Devices team.