EUDAMED Technical Consultant

Vision Achievement Limited; London; Remote; GBP 40,000 - 80,000; Full time

Job summary

An established industry player is seeking a highly skilled EUDAMED Technical Specialist Consultant to ensure compliance with EU medical device regulations. This fully remote role involves collecting, organizing, and validating data for the European Database for Medical Devices (EUDAMED), along with executing mass uploads and troubleshooting errors. The ideal candidate will have a strong background in regulatory affairs, proficiency in XML, and excellent attention to detail. If you are passionate about ensuring technical compliance in a dynamic environment and have the expertise to navigate complex data management processes, this opportunity is perfect for you.

Qualifications

• Expertise in EUDAMED data preparation and mass upload processes.
• Fluency in French and English is essential for this role.

Responsibilities

• Collect and format data to meet EUDAMED requirements.
• Execute mass uploads of device data using XML formats.

Skills

Data preparation

Data validation

XML file generation

Regulatory compliance

Problem-solving

Attention to detail

Communication skills

Education

Bachelor's degree in regulatory affairs

Bachelor's degree in life sciences

Tools

Excel

Database systems

Validation tools

Job description

EUDAMED Technical Specialist Consultant (Contract)

Overview

This job is for a client in France - fully remote.

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

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

Qualifications

1. Bachelor's degree in regulatory affairs, life sciences, or a related field.
2. Fluent in French and English.
3. Proven experience with EUDAMED, including data preparation and mass upload processes.
4. Familiarity with MDR/IVDR regulations and their application in medical device submissions.
5. Hands-on experience with XML file generation and validation tools.
6. Proficiency in data management tools, including Excel and database systems.
7. Strong understanding of XML, UDI (Unique Device Identification), and EUDAMED submission protocols.
8. Ability to troubleshoot technical issues and implement solutions efficiently.
9. Excellent attention to detail and organizational skills.
10. Strong problem-solving and analytical abilities.
11. Effective communication and interpersonal skills - the ability to consult with flexibility.
12. Prior experience working in medical device companies or consultancies.
13. Familiarity with other global medical device databases or systems (preferred).

Contract

1. Consultancy (short-term contracts based on client requirements).
2. Primarily remote with occasional business travel to client site(s).
3. Competitive daily rate.

Summary

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