Clinical Evaluation Specialist
Clinical Evaluation Specialist
Posted on :
06-05-2025
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1 Vacancy
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Job Description
Work Flexibility: Hybrid
Who we want:
Detailoriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes finding ways to simplify standardize and automate.
Selfdirected imitators. People who take ownership of their work and need no prompting to drive productivity change and outcomes.
Analytical problem solvers. People who go beyond just fixing to identify root causes evaluate optimal solutions and recommend comprehensive upgrades to prevent future issues.
Goaloriented developers. Keeping the customer and requirements squarely in focus people who deliver safe and robust solutions.
Delivers results. A driven player who sets high goals for personal achievement and organizational success. He/she measures success against the best internal and external benchmarks
What you will do
The Clinical Evaluation Specialistactsas the lead technical expert in driving this highly complex and demanding regulatory and project management skills toestablish theevaluationstrategy andtocompile the body of Clinical Evidence allowingin collaboration with the Medical Experttoreach a legally binding scientific conclusion on the safety and performance ofdevicesin patients throughout the product lifecycle.
The Clinical Evaluation Specialistbearstheoperational and regulatoryresponsibility ofindividual clinical evaluation reportsand may defend them in audit situations.
Tasks include
Driving the establishment of a coherent Clinical Evidence strategy throughout the new product development cycle and fostering alignment with adjacent complex processes (Marketing strategy and claims regulatory strategy clinical research strategy testing strategy).
Designingcompliant and sustainable literature search strategies and performingcomplex literature queries toretrievepublished clinical data
Identifying appraisingand analyzingall relevant (clinical PMS marketing and testing data) from multiple sources and formats and create a comprehensive scientific review including in depth statistical analyses risk management crosscheck and descriptive analyses following complex and rigorous methodologies.
Analyzingthe current medical and scientific trends in the clinical State of the Art on a broad variety of specialized indications and techniques.
Based on a detailed and uptodate understanding of US European and Australian regulatoryrequirementsand expectations elaborate and defend with the Medical Expert a conclusion on the overall riskbenefit statement.
Identify unanswered questions and residual risks in the Clinical Evidence and design Post Market Clinical Follow Up activities in collaboration with Clinical Research to address these questions.
Defining anddevelopingClinicalEvaluation and analysis methodologies to adapt to a complex and quickly evolving regulatory and scientific framework.
SupportingMarketing in the creation and review of collateral and promotional material to ensure alignment of messaging and claims to regulatory compliance scientific accuracy and clinical evidence.
With the Medical Experts helpingto define plan and initiate clinical studies and in vitro tests together with all stakeholders from Clinical Research R&D Biomechanics and Regulatory.
What you need:
Education: University degree (PhD Masters or equivalent) in a field related to the life sciences or a relevant medical engineeringfield (biology physiology biomaterials biomedical engineering or similar).
Experience: 3to5years of experience in Scientific or Medical Writing and/orrelevantacademicor clinicalresearch experience (PhD Postdoc)
Experience in clinical or regulatory affairs preferred
Experience withorthopedic or trauma devices preferred
Proactive independent team player with a strong service mentality.
You arecharacterized by analytical and transdisciplinary reasoning with a good attention to detail.
You value an international working environment working across sites and indications.
Travel Percentage: 10%Required Experience:
Unclear Seniority
Employment Type
Full-Time
Key Skills
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