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Quality Assurance Specialist
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Role: QA/RA Medical Devices SpecialistLocation: LiegeSalary: €55,000 + Company carIndustry: MedTechRole type: HybridAbout the jobAs 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.ResponsibilitiesStay up to date with regulatory requirements, assess potential medium- and long-term risks and impacts, and communicate them to company stakeholdersParticipate in identifying applicable regulatory requirements for the different markets targeted by the commercial departmentsSupport the integration of regulatory and normative requirements (IEC 60601, ISO 62304, etc.) into product development processes and educate teams on product-related requirementsProvide regulatory guidance to establish the most appropriate regulatory strategy and integrate medical device and software requirements into the quality systemContribute to the preparation of regulatory dossiers (CE marking, 510(k), etc.), manage their lifecycle, and maintain these authorizationsEnsure that regulatory files at subcontractors are properly updatedParticipate in the submission of regulatory dossiers to competent authorities and notified bodiesTake 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 devicesMonitor 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 strategyProfileMaster's degree in a technical field (mechanical, electromechanical, biomedical engineering, etc.) or equivalent experienceMinimum 3 years of experience in a similar roleKnowledge of ISO 13485, ISO 14971, ISO 62304 standardsKnowledge of GAMP-5; IEC 60601 is an assetKnowledge of medical device and machinery regulationsFluent in EnglishProficient in Microsoft Office suite
