• Clinical Evaluation Specialist - Active Implantable Medical Devices

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

    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 with up to 25% travel.

     

    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

    About You

    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 Bachelor's, Master's, 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 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)

     

    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.

    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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