QARA

👉 About OWLO

Founded as a spin-off from CNRS lab Institut Langevin, OWLO is building next generation microscopy for healthcare.

Our unique technology is the first to provide real-time 3D imaging in a non invasive way. This innovation will change research and medical practice by making visible and quantifying what was previously not accessible.

Our first use case is in Assisted Reproductive Technologies (ART) where 75% of embryos transfers fail today, resulting in long and expensive procedures that are very stressful and demanding for women. We provide an entirely new way of looking at oocytes & embryos with new indicators to predict their viability before implantation to improve the efficiency of the procedure and reduce its cost.

Website: https://www.owlo.io/

LinkedIn: https://www.linkedin.com/company/owlosas

We are a motivated team of researchers and developers, experts in Physics, Mathematics and Computer Science and are looking for a QARA to help us to bring to market our product to further push the limits of microscopy and ART. We are based at the heart of Paris, in the vibrant Latin Quarter, temple of science and knowledge, with great offices and a roof terrace.

Our product is composed of 2 parts: (i) OWLOScope - the hardware - composed of basic photonic elements, that is a module that can be plugged to any standard inverted microscope used in clinics & labs; (ii) OWLOCode - the software - that drives the OWLOScope and gives to the users our new imaging modality and predictive scores.

Working directly with the CTO and a consulting firm, you will be key to obtain CE/FDA approval for OWLO’s products by:

you will:

• Document and maintain the Quality Management System (QMS)
• Lead the preparation and submission of technical and clinical files (CE, FDA)
• Manage interactions with the notified body, handle audits → getting ISO 13485 within the year
• Support operational teams and processes (R&D, production, clinical, sales, customer service)

In the future, you will:

• Coordinate R&D activities to ensure compliance of developed products
• Handle product registration procedures with national authorities
• Conduct regulatory intelligence, update the QMS, train and raise awareness among teams
• Manage regulatory changes for medical devices in various countries

You will collaborate with all the members of OWLO.

• You are passionate about Medical Device
• You have a degree in QARA & 3+ years of experience
• You have at least one experience of regulatory approval for MDR
• Able to work on collaborative environment (Notion)
• Professional English (writing/oral)
• Excellent writing skills
• Autonomous and rigorous team player who does not hesitate to make propositions
• FDA experience is a plus

Don’t hesitate to apply even if you don’t fit 100% to the requirements but are eager to learn.

• Join a stimulating environment, at cross roads between lab & start-up incubators, in the heart of Paris 5th.
• Health insurance
• Tickets resto
• Travel (Navigo / bike subscription)
• Work from home possible