QARA Director

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 Director

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, you will:

• Own regulatory affairs and quality affairs for Incepto.
• Define and manage comprehensive regulatory strategies through all phases of development and product lifecycle.
• Own the overall company performance in meeting the medical device regulation (European MDR)
• Own the overall compliance of the company’s processes and products to any mandatory or elective regulatory / quality requirement set by the organization.
• Share QA/RA expectations with Incepto team members.
• Set up and regularly update the Quality Management System of Incepto
• Monitor Quality KPI’s
• Lead trainings and communication actions in favor of compliancy with applicable Laws, Regulations, Standard and Precedent cases.
• Conduct internal, certification and regulatory audits in collaboration with impacted functions.
• Ensure product registrations in the different market targeted by Incepto
• Manage Post market activities including recalls, field actions, and adverse event reporting

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 Law, 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.

Qualifications/Requirements:
• Previous experience with Quality Systems for medical devices and product registration (CE marking and 510K FDA)
• Strategic thinking ability
• A proven track record of regulatory successes
• 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)