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
