QARA Specialist

Incepto recrute !

À propos

What we do:
We co-create and distribute AI applications for medical imaging - bridging the gap between Physicians and Engineers.

Why we do it:
With more and more data, medical imaging is becoming more and more complex. We use Artificial Intelligence technology to transform medical imaging. This is a fantastic opportunity to empower physicians, saving them time, bringing them closer to their patients, and helping most of the population get access to the best modern care.

How we do it:
A journey is not only about what we do but also about how we do and look at things. We place our values at the heart of our work.
Centered on customer needs, the foundations of our unique team are:
Sharing, Expertise, Passion & Humility, Integrity

Descriptif du poste

Join us as QA/RA specialist

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

Profil recherché

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.

Process de recrutement

1 phone call interview then 2 to 3 interviews. Hiring process closed in a few days.

Location: Tour Montparnasse, 53ème étage, 33 avenue du Maine, 75015 Paris, France

Informations complémentaires

  • Type de contrat : CDI
  • Lieu : Paris, France (75008)