Responsabilities

Stay informed about regulatory requirements, assess potential medium- and long-term risks and impacts, and communicate them to company employees
Help identify the regulatory requirements applicable in the various markets targeted by the sales departments
Support the integration of regulatory and normative requirements (IEC 60601, ISO 62304, etc.) into the product development phase processes and provide training on product-related requirement
Provide regulatory advice to establish the best regulatory strategy and integrate medical device and software requirements into the quality system
Participate in drafting regulatory files (CE marking, 510(k), etc.) and managing the lifecycle of these files, as well as maintaining these authorisations
Ensure that regulatory files are kept up to date by subcontractors
Participate in the submission of regulatory files to the various competent authorities and notified bodies
Participate in registrations (company, products) in regulatory databases (EUDAMED, GUDID, AFMPS)
Ensure the monitoring and management of quality events (deviations, change control and CAPA) associated with operational quality processes and/or equipment – medical devices
Monitor medical device vigilance events
Participate in the assessment of the regulatory impact in the management of change control and deviations and collaborate with other departments to establish the best communication strategy.

Profil

You have a Master’s degree in a technical field (mechanical/electromechanical/biomedical/etc.) or equivalent experience
You have at least 3 years’ experience in a similar role
You are familiar with the ISO 13485, ISO 14971 and ISO 62304 standards
Knowledge of GAMP-5 and IEC 60601 standards is a plus
You are familiar with regulations specific to medical devices and machinery
You are fluent in English
You are proficient in Microsoft Office.

Would you like to become a key player in the global fight against cancer?

At Trasis, we offer you the opportunity to work with cutting-edge technologies and contribute to improving cancer diagnosis and treatment techniques. Through your work, you will have the opportunity to make a positive impact on the services provided to users and patients.

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

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

An attractive and flexible salary based on your experience and performance, with extra-legal benefits.

QA & RA Specialist – Equipment/Medical Device