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Quality & Regulatory affairs – F/H

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Présentation société

Each year, 140M children are born. Birth defects affect 1 in 33 births in developed countries, and in 50% of cases, they are not detected during prenatal examinations. Prenatal medicine is particularly complex, and the scans impose heavy responsibilities on healthcare professionals. They can also be a source of stress for future parents.

Resulting from 5 years of collaboration between world-renowned experts from Necker Hospital and Ecole Polytechnique, Sonio uses artificial intelligence to improve prenatal screening and diagnosis. Based on patented algorithms and a proprietary expert database, Sonio aims to become the reference tool to help practitioners improve screening, reduce diagnostic errors, and optimize pregnant women’s medical path.

Sonio’s mission is to improve women’s and children’s health by promoting access and quality of care through technological innovation, medical expertise, and collective intelligence.

Under the supervision of the quality and regulatory affairs manager, your responsibilities will be as follows:

50% support of quality activities

Ensure continuous quality system improvement and maintenance in accordance with the applicable regulations and standards (ISO 13485, FDA 21 CFR 820, etc.): review of processes, quality indicators, user feedback

Write and maintain QMS documentation (procedure, instructions, templates…)

Provide support for the implementation of digital QMS

Provide support in preparing audits and inspections

Assist in handling Non-conformities, complaints and implementing corrective actions

50% support of regulatory activities

Perform regulatory watch to ensure compliance with FDA regulations, ISO standards, and other relevant regulatory requirements and provide support for regulatory impact analysis

Provide support for regulatory submissions (assist in the preparation of technical documentation, ensure publishing of deliverables…)

Assist in regulatory impact assessments of device’s changes

Provide support for Countries registration (EUDAMED, local countries ...)

Provide support for Post-market compliance activities

Descriptif du profil

Ongoing Bac+5 in medical devices field in preference (engineering degree, master in regulatory affairs…)

Knowledge in medical devices, and software medical devices is a plus

Knowledge in quality and regulatory affairs is a plus

You are perfectly fluent in French and English

You value teamwork and you are team-oriented. This role will interact with most of the teams internally. Moreover, happiness and well-being are a priority in the way we’re building the team and we also want to be innovative here!

We move fast and aspire to be transparent over the process – our objective is that the process from the first chat to an offer is no longer than a month. We also aspire to give an answer to every application in a week – if you have not heard from us, please follow up at careers@sonio.ai.

Postuler

AIT AQQA Zahra
careers@sonio.ai

https://jobs.ashbyhq.com/sonio/5a6d50dc-bbe0-429c-ad30-6edf59f277e2