Senior Medical device documentation Associate
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Medical device documentation- Diagnostic Imaging and Interventional Radiology
- Knowledge of contrast media, injectors and disposables in medical imaging (MRI/CT)
- Experience in dossier preparation, compilation and submission for medical devices based on the legal manufacturer/physical manufacturer elements and the technical documentation
- Good understanding- of the medical imaging devices compliance from a global and regional perspective, registration procedures, preparation of answers to questions from health authorities
- Identification of regulatory risks and impact
- Experience in identifying label specific requirements and appropriate process and/or relabeling
- Expertise with regulatory management system and document management systems
- Effective communication and collaboration skills, and the ability to work independently