Role: QA/RA Medical Devices Specialist
Location: Liege
Salary: €55,000 + Company car
Industry: MedTech
Role type: Hybrid
About the job
As a QA & RA Device Specialist, you are responsible for activities related to the regulatory compliance of equipment, software, and medical devices, as well as for monitoring the quality records of these products (in particular regulatory contacts with subcontracted medical device manufacturers).
You contribute to the development of future company products, the maintenance of existing products, and support the continuous improvement of products and processes. You interact and collaborate with various teams to collect and validate the accuracy of working data. You play a key role in promoting a regulatory and compliance culture, both internally and externally.
Responsibilities
* Stay up to date with regulatory requirements, assess potential medium- and long-term risks and impacts, and communicate them to company stakeholders
* Participate in identifying applicable regulatory requirements for the different markets targeted by the commercial departments
* Support the integration of regulatory and normative requirements (IEC 60601, ISO 62304, etc.) into product development processes and educate teams on product-related requirements
* Provide regulatory guidance to establish the most appropriate regulatory strategy and integrate medical device and software requirements into the quality system
* Contribute to the preparation of regulatory dossiers (CE marking, 510(k), etc.), manage their lifecycle, and maintain these authorizations
* Ensure that regulatory files at subcontractors are properly updated
* Participate in the submission of regulatory dossiers to competent authorities and notified bodies
* Take part in company and product registrations in regulatory databases (EUDAMED, GUDID, FAMHP/AFMPS)
* Ensure follow-up and management of quality events (deviations, change control, CAPA) related to operational quality processes and/or medical devices
* Monitor vigilance and post-market surveillance events (medical device vigilance)
* Participate in evaluating regulatory impact during change control and deviation management, and collaborate with other departments to define the most appropriate communication strategy
Profile
* Master’s degree in a technical field (mechanical, electromechanical, biomedical engineering, etc.) or equivalent experience
* Minimum 3 years of experience in a similar role
* Knowledge of ISO 13485, ISO 14971, ISO 62304 standards
* Knowledge of GAMP-5; IEC 60601 is an asset
* Knowledge of medical device and machinery regulations
* Fluent in English
* Proficient in Microsoft Office suite