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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!

**Mission:**
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).

**Qualifications/Requirements:**
• 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.

Postuler

Christel Recco
christel.recco@incepto-medical.com

https://incepto-medical.welcomekit.co/



Dernière mise à jour : 17/05/2022