Overview
Facility Engineer Jobs in Roma at Johnson & Johnson
R&D Engineer/Risk Manager – Medical Devices
CDI – based in Colleretto (Italy)
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 with :
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.
You will be report to the Chief Development Officer.
Your 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;
Your 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.
The +
A pleasant and dynamic working environment
A company on a human scale
Are you keen to take on new challenges? Apply now!
Risk Management File / Risk Management Process / 14971 / Risk Management Analysis / Risk Management Activities
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Title: Facility Engineer
Company: Johnson & Johnson
Location: Roma
