• Clinical Evaluation Specialist - Active Implantable Medical Devices

    Location(s) US-FL-Tampa
    Category
    Healthcare
    Contract Type
    Perm Full-Time
    Salary
    Competitive Salary
  • About the Role

    BSI is hiring homebased Clinical Evaluation Specialists to join our Global Medical Devices business. This is an excellent opportunity to join a leading Notified Body, drive up the standard of safety and performance of Medical Devices for patients, and to be involved in the evaluation of cutting edge innovation and state of the art technologies. This position is intended for individuals with a background in medicine or nursing that have strong experience in the clinical field and deep knowledge about medical devices.

     

    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 Specialists 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.

    This homebased position is full-time, salaried, and involves up to 25% travel by car and plane for client meetings, trainings, and team meetings. 

     Medical Devices | Clinical | AIMD | Clinician

    About You

    The role requires you to have extensive experience with one or more of the following Active Implantable Medical Devices:

    • Neuro stimulator systems
    • Pace makers systems
    • Implantable cardioverter-defibrillator (ICD) systems
    • Implantable infusion pumps
    • Ventricular assist devices (VAD, LVAD)
    • Artificial hearts
    • Brachytherapy seeds and delivery systems
    • Cochlear implants
    • Implantable sensors including Medical Micro Electro Mechanical Systems (MEMS)

    Required Skills/Education:

    • Thorough knowledge of the design, development and implementation of clinical trials
    • 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.
    • Formal training as doctor of medicine (MD) or nurse
    • Bachelor’s degree in a discipline relevant to medical device manufacture and use (e.g. engineering, medical, nursing etc.), or equivalent qualification.
    • At least three (3) years’ experience in 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

    Only candidates who are a qualified doctor of medicine (MD) or nurse will be considered.

     

    About BSI

    Do you believe the world deserves excellence?

    BSI (British Standards Institution) has over 81,000 clients in 182 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.   #LI-MSFITZ

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