Risk Manager - Medical Device - H/F

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Bringing together 60 experts, Affluent Medical is a French MedTech company specialising in innovative, next-generation, minimally 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)

Reporting to the Chief Development Officer , the Risk Manager will be responsible for ensuring product safety for medical devices developed at Affluent Medical, by applying the risk management process throughout the product life cycle for all three programmes.

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.