About the Job
As a
QA Specialist
, you are responsible for activities related to the
regulatory compliance
of the company's
equipment, software, and medical devices
, as well as for the
follow-up of quality records
for these products (including regulatory contacts with subcontractors manufacturing medical devices).
Roles & Responsibilities
* Support the integration of regulatory and normative requirements (IEC 60601, ISO 62304, etc.) in product development processes and educate teams on product-related requirements.
* Provide regulatory advice to establish the most appropriate regulatory strategy and integrate medical device and software requirements into the quality management system.
Participate in the drafting of regulatory files (CE marking, 510(k), etc.), manage their lifecycle, and ensure the maintenance of approvals.
* Ensure that regulatory documentation is properly updated by subcontractors.
* Participate in the submission of regulatory dossiers to competent authorities and notified bodies.
* Support company and product registrations in regulatory databases (EUDAMED, GUDID, AFMPS).
* Ensure follow-up and management of quality events (deviations, change controls, CAPAs) related to operational quality processes and/or medical devices.
* Monitor vigilance events (material or device incident reports).
* Contribute to the regulatory impact assessment in change control and deviation management, and collaborate with other departments to define the most effective communication strategy.
Profile
* Master's degree in a technical field (mechanical, electromechanical, biomedical, etc.) or equivalent experience.
* Minimum 3 years of experience in a similar role.
* Knowledge of ISO 13485, ISO 14971, and ISO 62304 standards.
* Knowledge of GAMP 5 and IEC 60601 standards is an asset.
* Understanding of medical device and machinery regulations.
* Fluent in English.
* Proficient in Microsoft Office Suite.