Englefield Green, UK
Posted: Jan 26, 2024
RemoteFull-time
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Skills Required
Clinical Trials
expert
Development
expert
Clinical Study Documents
Proficient
Clinical Data
Proficient
Clinical Data Analysis
Proficient
Neurosurgery
Proficient
Nice To Have skills
Job Description
As a Clinical Evaluation Specialist within our team you will be responsible for:
• Performing detailed and timely assessments of manufacturers’ clinical evaluations of their AIMDs, to ensure that Active Implantable Medical Devices meet the safety and performance requirements of the MDR.
• Effectively communicating with manufacturers during the assessment, asking questions and identifying gaps in evidence.
• Working with team members and utilizing your clinical knowledge to guide other assessments within your areas of expertise and providing team training with the same aim.
• Working with Product Technical Specialists to determine the clinical impact of design changes and determining the level of clinical assessment required.
• Working with Internal Clinicians to ensure that the best External Experts are engaged in the clinical assessment process.

Education And Qualifications
• Degree in medically or biologically oriented discipline, such as medicine, veterinary medicine, medical science, biology, anatomy, physiology, biomedical engineering, pharmacy, nursing, allied health professional, medical scientist etc. or
• Degree in any scientific discipline combined with higher degree in medically or biologically oriented discipline or
• Degree in any scientific discipline combined with five or more years’ postgraduate experience in medical devices research or product development that involves direct interaction with clinicians and / or patients or has managed/designed clinical studies.

Work Experience
• Thorough knowledge of the design, development and/or implementation of clinical trials, or experience of the running of clinical trials in your field of expertise
• Post graduate experience with AIMDs involving clinical study design or management or clinical data evaluation and systematic reviews of clinical literature
• Experience with AIMD product training including providing product support and guidance to surgeons and physicians on implant techniques, product performance and product management,
• Experience in the programming of AIMDs and the management of patients treatment related to AIMDs
• Experience working in Neurosurgery and/or neurostimulators, or a background in implantable brachytherapy devices.

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Additional Info
Min. Experience
-
Job Location
Remote
Job Type
Full-time
Job Seniority Level
-
Job Duration
Any
Language(s)
English
Est. Budget/Pay Rate
To be discussed
Est. hrs
-
Optimal Job Start
-
Job Industry
-
Job Function
-
Applicant Countries
United Kingdom,
Job Ref
J243825FE6FCD