Chargé d’Affaires Réglementaires Dispositifs Médicaux IV F/H

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Client:

Consultys

Location:

Lyon, France

Job Category:

-

EU work permit required:

Yes

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Job Reference:

9c8cd5ef2061

Job Views:

3

Posted:

24.04.2025

Expiry Date:

08.06.2025

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Job Description:

Missions

CONSULTYS is recruiting for a CDI position a Chargé d’Affaires Réglementaires – Dispositifs Médicaux F/H to work with one of its clients in Medical Devices. Your responsibilities will include:

• Renewing registrations,
• Writing reports for new submissions,
• Preparing technical files,
• Drafting Change controls, assessing their impact, and implementing these changes.

The position is available immediately in the Lyon region.

Candidate Profile:

• You hold a degree in Engineering or University (Bac + 5) and have at least 2 years of experience in regulatory affairs within the medical devices field,
• You are familiar with relevant standards (ISO 13485, MDR 2017/745, MDR 2017/746 (IVD)),
• You are proficient in English, both spoken and written,
• You understand regulations related to market authorization dossiers (CEP, DMF, JDMF, etc.),
• You demonstrate good organizational and interpersonal skills and are rigorous.

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Interested in joining the consulting world within a human-sized company that values individuals and performance?

Looking to commit long-term to innovative projects?

Want to share your skills within a close-knit team where experiences are freely shared?

Join us!

Consultys values diversity and inclusion and is committed to equal opportunities for people with disabilities.