EUDAMED Technical Specialist Expert
il y a 4 jours
We are seeking a highly skilled and detail-oriented EUDAMED Technical Specialist to support our client's organizational compliance with the European Union's medical device regulations (MDR and IVDR). The consultant will play a pivotal role in ensuring accurate and efficient mass data uploads into the European Database for Medical Devices (EUDAMED).
Key Responsibilities include:
- Collecting, organizing, and formatting data to meet EUDAMED requirements.
- Ensuring data integrity and accuracy by validating entries against regulatory standards.
- Working with internal teams to address missing or incomplete data.
- Executing mass uploads of device data into the EUDAMED system using XML or other required formats.
- Identifying and troubleshooting errors during the upload process, providing timely resolutions.
The ideal candidate will have a strong understanding of regulatory requirements, expertise in data preparation, and proficiency in data management tools. Experience with EUDAMED, including data preparation and mass upload processes, is essential. Familiarity with MDR/IVDR regulations and their application in medical device submissions is also required.
A competitive daily rate is offered for this position, which includes primarily remote work with occasional business travel to client sites. Independent consultants with registered businesses are encouraged to apply.
This consultancy requires a bachelor's degree in regulatory affairs, life sciences, or a related field, fluency in French and English, and proven experience with XML file generation and validation tools.
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