01 ago
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Dormont Manufacturing
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Italia
01 ago
Dormont Manufacturing
Italia
We are the International Surgical division of Enovis, a global innovation‑driven company in the medical technology sector. Every day we are committed to improving patients’ quality of life by developing innovative and clinically differentiated solutions.
Regulatory Affairs Sustaining Specialist
Preparation, updating and management of technical documentation for the registration and maintenance of medical devices in accordance with Regulation (EU) 2017/745 (MDR).
Cross‑functional collaboration with product development, quality, clinical and manufacturing teams to gather necessary information for compiling technical files.
Regulatory management of product/process changes (e.g., structure of technical documentation, notification processes).
Degree in scientific disciplines (Biology, Chemistry, Biomedical Engineering, or related fields).
At least 1–2 years of experience in Regulatory Affairs within the medical device industry.
Knowledge of MDR and major international regulations applicable to medical devices.
Good time and priority management skills.
Excellent command of Italian and English (B2/C1 level).
Proficiency in Microsoft Office, especially Excel.
Strong interpersonal skills and ability to work in multicultural teams.
Availability for short business trips to Switzerland (2–3 days per quarter) is required.
Le decisioni relative all’assunzione si basano esclusivamente sul merito, sulle qualifiche e sulle esigenze aziendali. Applichiamo una politica di parità di trattamento per tutti i dipendenti e i candidati, senza discriminazioni basate su razza, colore della pelle, religione, nazionalità, sesso, orientamento sessuale, identità di genere, età, status di veterano, disabilità o qualsiasi altra caratteristica non correlata alle qualifiche o alle prestazioni lavorative di una persona.
Employment decisions are based solely on merit, qualifications, and the needs of the business. We uphold a policy of equal treatment for all employees and applicants, without discrimin
📌 Compliance Officer (Italia)
🏢 Dormont Manufacturing
📍 Italia