Scarlet
Healthcare
ClinicalEvaluationSpecialistRadiology
“Clinical Evaluation Specialist - Radiology at Scarlet. Skills: Clinical evaluation, Assessment of clinical data for medical devices, Regulatory insights. Assess and certify the most innovative and impactful medical device software. Conducting swift and accurate device assessments”
What You'll Achieve.
Hasten the transition to universally accessible healthcare; Enable market access, new device updates and ongoing surveillance of a growing portfolio of medical devices; Deliver fast and efficient assessments
Industry & Context.
Going down rabbit holes, understanding deeply how things work
What They're Looking For.
Must Have
Minimum of two years experience in patient care, clinical imagining, radiology operations, or related healthcare practice, Experience using medical device software or active non-implantable imaging devices utilising ionising radiation (e. g. x-ray computer tomography, gamma cameras, fluoroscopy, PET scanners), Minimum of two years experience with the assessment of clinical data for medical devices, Knowledge of the fundamental principles of the assessment of clinical data for medical devices and medical statistics, Practical experience in conducting or monitoring clinical investigations/trials or assessing clinical data
Nice to Have
Ferociously curious - You like going down rabbit holes, understanding deeply how things work, and challenging the status quo, Research savvy - You have knowledge of different clinical research methodologies, including experience designing or contributing to the development of clinical trials, Highly adaptable - You have worked in different environments and like operating with autonomy on sometimes ambiguous tasks, Guidance knowledge - You have knowledge or training in the relevant standards and guidance used for clinical evaluation (e. g. ISO 14155, MEDDEV 2-7/1 Rev. 4)
What You'll Do.
Assess and certify the most innovative and impactful medical device software
Conducting swift and accurate device assessments
Provide knowledge and expertise to internal functions and external stakeholders
Get authorised to assess the clinical evaluation processes of the most innovative medical devices in the world
Collaborate with a multidisciplinary team on technical documentation assessments
Create content to help explain complex regulatory topics to customers and prospects
Screen and action regulatory insights from the latest research
standards and guidance
Support the Sales and Customer Experience function by providing regulatory insights on prospects and customers
Work with our Product
Design and Applied ML functions to build and improve our systems
Support the Technical Operations function as they expand Scarlet’s approvals in various jurisdictions and technologies
How You'll Work.
Team & Collaboration
Collaborate with a multidisciplinary team on technical documentation assessments; Support the Sales and Customer Experience function; Work with our Product, Engineering, Design and Applied ML functions; Support the Technical Operations function
Communication Scope
Excellent written & verbal communication skills
Applying for this Clinical Evaluation Specialist - Radiology role?
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