Description
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
Company
Parexel designs and delivers clinical trial solutions across Phase I–IV, combining clinical, regulatory, and therapeutic expertise to accelerate drug development with a patient-first mindset.
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