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.
* Support CAPA investigations and track corrective actions.
* Assist with internal audits and external audits.
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Job Requirements:
* Bachelor's degree or higher in Life Sciences, Engineering, or related field.
* 2–5 years of experience in QA/RA within a regulated industry (medical devices preferred).
* Working knowledge of ISO 13485, ISO 14971 and EU MDR.
* Good communication skills and ability to work cross-functionally.
* Pragmatic problem solver with attention for detail.
* Proactive work ethic.
Operating Company:
DEXIS
Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.