Job Description
Job Description
:DEXIS, part of the Envista family, is a global leader in dental imaging technology, dedicated to streamlining clinical workflows and advancing an AI-powered digital ecosystem. Our mission is to empower dental professionals to deliver better, more predictable patient outcomes through intuitive, innovative technology.
As an RA Specialist at DEXIS in Mechelen, you will work closely with R&D and cross‑functional teams to bring our products to market efficiently, enabling timely development cycles and smooth market introduction.
Preparing regulatory submissions (EU MDR, FDA, other markets).
Perform assigned product registrations and notifications.
Maintain QMS documentation and ensure compliance with ISO 13485, ISO 14971, and IEC 62304.
Participate in risk management activities and post-market surveillance.
Support product development from a QARA viewpoint.
Sup...
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