Risk Manager - Aix-en-Provence, France - Recrutis

Recrutis

Entreprise vérifiée

Aix-en-Provence, France

il y a 3 semaines

Posté par:

Sophie Dupont

beBee Recruiter

Description

Bringing together 60 experts, Affluent Medical is a French MedTech company specialising in innovative, next-generation, mínimally invasive implants designed to restore essential physiological functions in the treatment of heart disease and urinary incontinence.

Affluent Medical's medical devices are currently in the clinical phase:

EPYGON, 1st biomimetic transcatheter mitral valve ;:

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KALIOS, 1st post-operative adjustable annuloplasty implant to address recurrence;:

ARTUS, the 1st artificial sphincter for the treatment of urinary incontinence that can be remotely activated electronically.

In order to support the development of these devices, we are looking for a:

Risk Manager M/W

This position is based in Aix en Provence OR in Colleretto Giacosa, Piémont (25% travel)
In collaboration with the Quality, Regulatory, Clinical, Marketing and R&D teams, you will be responsible for:

Planning and executing the risk management process, preparing and updating the risk analysis for medical devices in accordance with the relevant standards and guidelines;
Creating or updating the risk management file;
Creation of the countermeasures specification (e.g. requirements management);
Transfer of risk management to production;
Alignment of risk analysis with usability files;
Creation of risk assessments for complaints;
Participating in regulatory inspections and audits of notified bodies as a risk management expert;
Promotion of continuous improvement efforts;
Creation and monitoring of compliance indicators.

Profile:

You have a scientific degree (Bac+5) in biomedical, mechanical engineering, industrial design or electrical engineering,

You will have at least 5 years' experience in Risk Management in DM environment. You have a solid knowledge of the regulatory framework (MDR 2017/745, ISO 14971, ISO 13485, 21CFR).

You are necessarily fluent in English.

You are details-oriented and are used to working with a start-up spirit in a dynamic and innovative context. You have a strong interpersonal and communication skills within multi-disciplinary teams