Responsibilities

You participate in the company’s quality/regulatory strategy in each of its areas of equipment use.
You organize the QA & RA medical device/equipment department and define the associated strategic missions.
You draw up objectives (quality, regulatory and operational) and ensure their effective implementation.
You motivate, federate and manage the department. You ensure the implementation of performance indicators (KPIs) to manage and coordinate the department’s activities.
You maintain an overview of the market’s QA & RA needs to support internal product development.
You are in charge of regulatory watch.
You provide advice to sales departments on the global regulatory landscape impacting medical equipment and devices, and define a go-to-market strategy.
You coordinate the drafting of CE marking dossiers and the life-cycle management of CE marking dossiers, as well as the maintenance of these authorizations.
You ensure that subcontractors’ regulatory files are properly updated.
You are the point of contact with health authorities/notified bodies concerning medical devices (distribution, manufacturing, etc.).
You represent Trasis’ strategic interests in various working groups relating to medical devices and equipment (IEC,…

Profile

You have a Master’s degree in a technical field (mechanical/electromechanical/biomedical/…) or equivalent through experience.
You are familiar with equipment standards and directives (IEC/Machine Directive, etc.).
At least 5 years’ experience in a similar position.
Experience in the field of medical devices and/or pharmaceuticals is an asset.
You have a good command of written and spoken English.
You have experience in the design and development of Quality Management Systems (methods, procedures).
You have good risk assessment skills.
You know how to study, formalize, monitor and communicate quantitative and qualitative indicators.

Do you want to become a major player in the global fight against cancer?

At Trasis, we give you the opportunity to work with cutting-edge technologies and contribute to the improvement of cancer diagnosis and therapy techniques. Through your actions, you will have the opportunity to have a positive impact on the services provided to users and patients.

The opportunity to participate in building and improving processes in a growing company.

We offer a young and friendly work atmosphere, a flexible and dynamic environment.

An attractive and flexible salary according to your experience and performance, with extra-legal benefits.

Device Quality Manager

Device Quality Manager