Clinical Expert - Medical Devices (m/f)
The Clinical Expert will be involve in various tasks, such as: regulatory and clinical development planning for new design and for changes in current product, collaboration with In-house experts covering all subjects related to CE-marking of medical devices, Clinical Study / Performance Evaluation planning and management, evaluation and interpretation of results
Client Details
Our Client is a world-leading medical device company with more than 20 years of experience on the global market. We are looking for a person, which the main goal will be conduct the assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer.
Description
- Identify the Essential Requirements that require support from relevant clinical data
- Identify available clinical data relevant to the device and its intended use
- Evaluate data in terms of its suitability for establishing the safety and performance of the device
- Generate any clinical data needed to address outstanding issues
- Bring all the clinical data together to reach conclusions about the clinical safety and performance of the device
- Medical writing of clinical evaluations / Performance evaluations
- Interaction with international Competent Authorities to up date the requirements for clinical evidence and clinical requirements
- Development of creative solutions in order to fulfill client needs combined with regulatory requirements
Profile
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University degree - scientific, medical or paramedical equivalent Minimum 5 years of experience in clinical research (Pharma Company, medical device company or CRO)
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Strategic planning of clinical concepts for intended use of the product including statistical justification
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Development of medical devices products
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Clinical study / performance evaluation planning (academia, industry, CRO) experience in this area needed and working as monitor for such study is required
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Writing documents needed for regulatory purposes such as clinical evaluation report base on literature, clinical post market clinical follow up study
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Experience in medical device industry, preferably in regulatory affairs and/or quality management related positions
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Project management skills
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Written and oral communication skills in English
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Prior clinical specialist experience for a medical device or pharmaceutical manufacturer, and clinical experience in the healthcare environment
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Knowledge of clinical trials regulations and guidelines
Job Offer
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Possibility to develop in the international company with outstanding products and excellent working standards
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Attractive compensation package
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Great career prospects in the dynamic environment full of experts passionate about their work and mission
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A number of internal and external trainings
Location: Ozorków
Contract type: Na czas nieokreślony
About Michael Page
Michael Page is a leading professional recruitment consultancy specialising in the recruitment of permanent, contract and temporary positions on behalf of the world's top employers.
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