Clinical Evaluation Specialist

Description: Great that you're thinking about a career with BSI!BSI is seeking Clinical Evaluation Specialists to join one of the following medical device technical teams: Vascular, Active Implantable, Active, and Orthopaedic. 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 home-based position is full-time, salaried, and involves up to 15% travel by car and plane for client meetings, trainings, and team meetings. Clinical Evaluation Specialist Responsibilities:Carry out detailed assessments of clinical data to ensure that medical devices meet the safety and performance requirements of the regulationsCompile Clinical Evaluation Assessment Reports (CEAR?s)Manage the submission of CEAR?s and supporting documentation to the EU Commission for clinical evaluation consultation, including addressing any feedback receivedWork with Product Technical Specialists to determine the clinical impact of design changes and determine the level of clinical assessment required and ensure that the clinical aspects of Design Dossier and Technical File Reviews are completed on timeWork with Internal Clinicians to ensure that the relevant External Clinical Experts and Clinical Statisticians are engaged in the clinical assessment process and clinical requirements of the Medical Device Directive and Medical Device Regulations are being metParticipate in client meetings to facilitate CE marking processesKeep up to date with regulatory requirements and maintain a high level of awareness of changes in standards relating to the voluntary and mandatory certification in Europe and internationallyEducation/Qualifications:Medical training required (doctor of medicine (MD), registered nurse (RN), radiographer, medical physicist, (respiratory) physiotherapist or other allied healthcare professionalBachelor?s degree in a discipline relevant to medical device manufacture and use (e.g. engineering, medical, nursing etc.), or equivalent qualification.Thorough knowledge of the design, development and implementation of clinical trialsThe role requires you to have extensive experience with one of the following medical device technologies:Vascular ? stents and stent delivery systems, percutaneous heart valves, devices to treat abdominal aortic aneurysms ablation and electrophysiology catheters, neurovascular experience (embolic coils, neurovascular stents and related accessories), cardiovascular devices such as balloon catheters, PICC or CVC catheters, guide wires, introducers, closure devices and related accessories.Active ? ablation devices, hearing aids, infusion pumps, ventilators, software devices, x-ray machines, heart-lung machines, patient monitors, radiation therapy, surgical lasers, ultrasound devicesActive Implantable ? Neurosurgery and/or neurostimulators, Pacemakers, Implantable Cardioverter-Defibrillators (ICDs), Ventricular Assist Devices (VADs), Spinal Cord and Deep Brain Stimulators (SCS/DBS), and implanted brachytherapy devicesOrthopaedic ? hips, knees, spine, major jointsWorking knowledge of ISO 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//EEC.Five or more years? post graduate experience with Medical Devices involving Clinical study design or management or clinical data evaluation and systematic reviews of clinical literature or Device product training including providing product support and guidance to surgeons and physicians on implant techniques, product performance and product management.What we offer:BSI offers a competitive salary, ample annual leave/paid time off, and other robust benefits depending on country.Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.