Risk Management Specialist

il y a 2 semaines

AixenProvence, France Recrutis Temps plein

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;
- 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

Vos missions

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.

Vos compétences

**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.

Avantages

45k-55k fixe annuel sur 12 mois, 10% de variable, BSPCE

**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).

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