パレクセルでの仕事
パレクセルは、臨床開発の上流から下流までのそれぞれの専門領域で、国内外の多くのお客様に高度なソリューションを提供するプロフェッショナル集団です。 パレクセルは、新しい薬や治療法を、それらを必要としている人々にいち早く届けることを目指し、日々の業務に取り組んでいます。
Senior Medical device documentation Associate
応募 求人ID R0000038450 ロケーション インド 仕事内容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
