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QARA Specialist F/H

Type de contrat : CDI
Région : Île-de-France
Niveau de formation : Bac 4/5
Rémunération : non précisé
Famille de métier : Qualité

Présentation société

*Incepto Medical
Saving Time. Saving lives. Together. *

Incepto co-creates and distributes AI applications for medical imaging – Bridging the gap between Physicians and the Tech world.
Incepto forms a passionate, expert and humble team, promoting collaboration and centered on customer and patient needs.

Join us and take on the challenge of AI in Medical Imaging! Together!

The challenge of Artificial Intelligence applications in medical imaging does not stop when Data Scientists and Software Engineers have delivered software even with the best performances. The software becomes a medical device usable in clinical routine when it complies with proper regulation and quality management system.

To achieve this mission, in collaboration with the QARA Director, you will:

• Update Incepto QMS and follow-up its performance and effectiveness
• Monitor Quality KPI’s
• Manage NC-CAPAs, change controls and complaints
• Conduct internal and external audits in collaboration with impacted functions.
• Participate to all phases of product development
• Help in developing/updating medical device regulatory files according to MDR 2017/745.
• Manage product registrations in the different markets targeted by Incepto
• Perform regulatory surveillance
• Share QA/RA expectations with Incepto team members.

Activities can be adapted depending on level of experience, expertise and motivation of the QARA specialist!

On top of a team of passionate co-workers, you will benefit from:
• Immersion in a clinical site with radiologists
• After-work, restaurants, barbecue, winter/summer meetings, shirts, mugs
• Participate to congress JFR, Vivatech etc…
• Remote work when you need

Descriptif du profil

Bachelors/master’s degree (or equivalent) in medical device, medicine, pharmacy, bio-engineering or related science, you have at least 1year of professional experience in regulatory affairs or in quality management systems relating to medical devices (all levels of experience accepted).

• Good organizational and communication skills
• Ability to work independently, prioritizes multiple projects and addresses multiple issues
• Team work
• Fluent in English
• Rigorous, curious

**Desired skills:**
• Passionate with technology and innovation applied to medical domain.
• Knowledge of Software specifics for medical devices
• Positive experience in communicating with Regulatory Authorities
• Continuous improvement minded.


Christel Recco

Dernière mise à jour : 17/05/2022