Risk Manager
Il y a 7 mois
**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 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
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