Risk Manager

Il y a 2 mois

AixenProvence, France RECRUTIS Temps plein

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.

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

- EPYGON, 1st biomimetic transcatheter mitral valve;
- 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:
**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.

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.

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.**:

- ** A salary in line with the current market, based on your experience;**:

- ** 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.

Nous travaillons principalement sur des opportunités en CDI.

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