Senior Medical device documentation Associate
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. 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