Risk Manager - Aix-en-Provence, France - RECRUTIS
Description
Recrutis is recruting for his client : Affluent Medical
Bringing together 60 experts, Affluent Medical is a French MedTech company specialising in innovative, nextgeneration, mínimally invasive implants designed to restore essential physiological functions in the treatment of heart disease and urinary incontinence.
- EPYGON, 1st biomimetic transcatheter mitral valve;
- KALIOS, 1st postoperative adjustable annuloplasty implant to address recurrence;
- ARTUS, the 1st artificial sphincter for the treatment of urinary incontinence that can be remotely activated electronically.
Risk Manager M/W
This position is based in Aix en Provence (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.
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.
Remuneration starting at 45k fixed + 10% variable.
Joining Affluent Medical means:
-
Participating in the development of the new generation of mínimally invasive prostheses for the treatment of urinary incontinence and mitral valve disease;:
-
Helping to bring to market cutting-edge solutions that will radically change millions of lives;:
-
Be part of an innovative programme in the rigorous field of cardiac surgery
:
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A salary in line with the current market, based on your experience;:
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Involvement in a programme in synergy with all the entities of the Affluent Medical group, spread over three sites: Aix en Provence, Besançon and Colleretto (Turin
- Italy);
Join a dynamic and motivated team;:
-
Continuous learning (training courses available).
Qui sommes nous ?
Nous sommes un cabinet de recrutement externe spécialisé depuis une dizaine d'années dans les Lifesciences, principalement dans le domaine du Pharmaceutique/Dispositifs Médicaux/Industrie Chimie, qui recrute des profils qualifiés pour des clients qui sont des entreprises dans les domaines précisés ci-dessus.
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