About Us 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. Job Title Regulatory Affairs Sustaining Specialist Responsibilities * 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., reportability assessment, notification of changes to notified bodies/competent authorities). * Handling communications with notified bodies and competent authorities (e.g., responses to deficiencies and/or requests for clarification). * Contribution to the analysis of deficiency reports and preparation of responses.



* Active participation in defining and improving internal regulatory management processes (e.g., structure of technical documentation, notification processes). Requirements * 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. * Accuracy, methodical approach, and results orientation. * Strong interpersonal skills and ability to work in multicultural teams. * Willingness to learn and collaborate. Availability for short business trips to Switzerland (2–3 days per quarter) is required. Equal Opportunity Enovis si impegna a garantire pari occasione di lavoro a tutti. Le

📌 Regulatory Affairs Sustaining Specialist (Italia)
🏢 Dormont Manufacturing
📍 Italia