Beschreibung
My client is an internationl medical device company and currently looking for support in the field of clinical evaluation. The project start is flexible (between April and June) und currently planned for one year.Responsibilities:
- Assess data and literature regarding clinical safety and clinical performance of the devices;
- Evaluate if clinical data available does have an impact on the risk-profile or existing overall clinical assessment of the device.
- Performs literature research and provides qualified input to Post-Market-Surveillance and Risk-Assessment function.
- Supports generation of required documentation to update existing technical documentation of products.
- Generate Clinical Evaluation Reports
- Execution, communication and reporting of feasibility, CE mark and post-marketing studies to enable the company to meet its business objectives
Your skills:
- Experience working with Medical Devices according to MDD/MEDDEV 2.7.1/ISO14155/ISO13485 standards
- Demonstrable clinical evaluation skills
- Knowledge of European regulatory environment
- Knowledge of/experience with medical writing, literature searches, scientific work, risk-benefit assessment, post marketing clinical follow-up
- Fluent in English and German
I am looking forward to your application!
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