EUDAMED Technical Expert

il y a 1 jour


Paris, Île-de-France Vision Achievement Temps plein

We are seeking a highly skilled EUDAMED Technical Expert to support our client's organizational compliance with the European Union's medical device regulations (MDR and IVDR).

This position requires expertise in data preparation, data validation to regulatory expectations, and uploading processes, along with a solid understanding of regulatory requirements.

Key Responsibilities:
  • Collect, organize, and format data to meet EUDAMED requirements.
  • Ensure data integrity and accuracy by validating entries against regulatory standards.
  • Work with internal client teams to address missing or incomplete data.
  • Execute mass uploads of device data into the EUDAMED system using XML or other required formats.
  • Identify and troubleshoot errors during the upload process, providing timely resolutions.
  • Monitor upload progress and maintain records of submissions and confirmations.
  • Stay up-to-date on EUDAMED requirements and MDR/IVDR regulations.
  • Ensure that all uploads and associated processes align with the latest EU medical device regulations.
  • Assist in preparing documentation and reports for audit or regulatory review.
  • Collaborate with regulatory, quality assurance, and IT teams to streamline data processes.
  • Provide guidance and training to team members on EUDAMED-related tasks as needed.
  • Act as a liaison between the client organization and external stakeholders for EUDAMED queries.
  • Recommend improvements to data management and submission workflows.
  • Develop templates, tools, and best practices to enhance the mass upload process.

The ideal candidate will have a Bachelor's degree in regulatory affairs, life sciences, or a related field. Fluency in French and English is also essential. Prior experience with EUDAMED, including data preparation and mass upload processes, is necessary. Familiarity with MDR/IVDR regulations and their application in medical device submissions is also required. Proficiency in data management tools, including Excel and database systems, is a plus.

This consultancy role offers a competitive daily rate and is open to independent consultants with a registered business. The primary work arrangement is remote with occasional business travel to client sites. Expenses will be paid upon pre-approval by the client.

At Vision Achievement, we strive to deliver exceptional results in a fast-paced environment. If you're an expert in navigating EUDAMED's complexities and possess a passion for ensuring technical compliance, we encourage you to apply.



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