EUDAMED Technical Consultant

EUDAMED Technical Specialist Consultant

Overview

We are seeking a highly skilled and detail-oriented EUDAMED Technical Specialist independent consultant 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). 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.

Qualifications

- Bachelor's degree in regulatory affairs, life sciences, or a related field.

- Fluent in French, and English 

- Proven experience with EUDAMED, including data preparation and mass upload processes.

- Familiarity with MDR/IVDR regulations and their application in medical device submissions.

- Hands-on experience with XML file generation and validation tools.

- Proficiency in data management tools, including Excel and database systems.

- Strong understanding of XML, UDI (Unique Device Identification), and EUDAMED submission protocols.

- Ability to troubleshoot technical issues and implement solutions efficiently.

- Excellent attention to detail and organizational skills.

- Strong problem-solving and analytical abilities.

- Effective communication and interpersonal skills - the ability to consult with flexibility.

- Prior experience working in medical device companies or consultancies.

- Familiarity with other global medical device databases or systems (preferred).

Contract 

- Consultancy (short-term contracts based on client requirements).

- Primarily remote with occasional business travel to client site(s)

- Competitive daily rate.

Summary

If you are an expert in navigating EUDAMEDs complexities and have a passion for ensuring technical compliance in a fast-paced environment, we encourage you to apply.