Develops appropriate regulatory strategy for bringing Macopharma Transfusion and Biotherapy products (Medical Devices and Drugs to the US). Identifies the status of the product according to the country (Medical Device, medicine ). Sets the elements necessary for the compilation of files according to the regulations and regulatory guidelines. Collects data to assess compliance with the expectations of the authorities. Edits and submits the registration file to the competent authorities or notified bodies. Develop good relationships with the authorities. Keeps abreast of regulatory changes and analyse whether these changes have an impact on our business. Exchange with the service Materio/Pharmaco/ Biovigilance as part of risk management plans, the submission of periodic reports vigilance and change requests for medical information.
Skills and Requirements
Education and experience with FDA submissions/registrations for medical devices and drugs. Four years degree required in scientific field. Ability to multi-task effectively under tight deadlines. Expertise with Microsoft Package. Excellent organization and follow-up skills. High level accuracy and attention to detail. High level of discretion and confidentiality. Ability to communicate in a clear and articulate manner.
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