pChi siamo ENOVIS™ Enovis Corporation (NYSE: ENOV) è un'azienda in crescita nel settore delle tecnologie mediche orientata all'innovazione e dedicata allo sviluppo di soluzioni clinicamente differenziate che migliorano in modo misurabile i risultati dei pazienti e trasformano i flussi di lavoro. Grazie a una cultura del miglioramento continuo, al talento globale e all'innovazione, l'ampia gamma di prodotti, servizi e tecnologie integrate dell'azienda alimenta stili di vita attivi in ortopedia e non solo. Per ulteriori informazioni su Enovis, visitare il sito We Are ABOUT ENOVIS™ Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit /ppcosa ti occuperai | What You’ll Do The Regulatory Market Access Specialist will work in the market access team to bring new and modified medical devices to market and ensure ongoing compliance. The Regulatory Market Access Specialist provides hands‑on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements and preparation of submissions. The Regulatory Market Access Specialist performs regulatory submission/approval activities for specific Enovis products. The Regulatory Market Access Specialist ensures compliance with required regulations and established corporate standards. The Regulatory Market Access Specialist ensures that product approvals are properly maintained, and product re‑registrations are properly managed. Regulatory Market Access Specialist will exercise creativity/innovation with expectations of independent research and use of accepted regulatory practices in the execution of tasks. /ph3Key Responsabilities /h3ulliHandles the preparation and processing of documentation required for new product introductions and modified products in international markets. /liliActs as a core team member on sustaining and new product development projects, providing regulatory feedback and guidance throughout the product development cycle.



/liliWorks with market access team and cross‑functional peers to resolve potential regulatory/technical issues and questions from the regulatory agencies in international markets. /liliPrepare documentation for international regulatory registrations and licenses /liliDefine regulatory requirements necessary for regulatory approval of Surgical for the countries under his/her responsability /liliManages the release and shipment of products under regulatory controls to all regions. /liliProvides recommendations for how to overcome regulatory barriers and resolve any disputes within teams as to the importance of regulatory requirements. /liliCoordinates and assists the Market Access Lead with defining regulatory requirements in Regulatory planning process. /liliReviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations and sends applicable notifications to license and registration holders in international markets. /liliMaintain all regulatory documentation to ensure availability for external audits and preparation of submission packages /liliProvides technical guidance and regulatory training to cross‑functional teams. /liliReviews device labeling and advertising materials for compliance with applicable regulations and recommends appropriate changes. /liliMonitor the development of new regulatory requirements and advise of the impact to cross‑functional teams. /liliDevelops and maintains procedures to ensure compliance and support business goals. /liliMaintains proficiency in government regulations and guidances. /liliSupport other regulatory requests or projects as needed. /li /ulh3Preferred Qualifications /h3ulliBachelor's or Master's degree in a scientific/technical discipline (B.Sc./M.Sc. in Biology or Chemistry, or B.E./B.Tech in Biomedical Engineering or related field). /liliZ Minimum of 2 years experience of medical device industry as a Regulatory Affairs Specialist /liliWorking knowledge of EU MDR and major international regulations and standards applicable to medical devices (e.G. ISO 13485, ISO 14971, ISO 15223-1,



ISO 20417, etc.). /liliPrior experience with regulatory submissions for medical devices in international markets (outside EU) /liliProficiency in Microsoft Office, especially Excel. /liliGeneral understanding of the product development process and design controls /liliAbility to manage several projects simultaneously /liliStrong interpersonal and influencing skills /liliAbility to independently manage projects, prioritize time and communicate effectively /liliExcellent command of English (spoken and written). /liliExperience using Agile PLM, Power BI, or similar tools is advantageous /li /ulpDichiarazione di pari opportunità Enovis si impegna a garantire pari possibilità di lavoro a tutti. 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. Questo impegno si estende a tutti gli aspetti dell'occupazione, tra cui reclutamento, assunzione, assegnazione dei compiti, retribuzione, formazione, promozione, retrocessione, trasferimenti, licenziamenti, provvedimenti disciplinari e cessazione del rapporto di lavoro, nonché a tutti gli altri termini e condizioni di impiego. /ppEqual Employment OpportunityAt Enovis, we are committed to providing equal employment opportunities to all individuals. 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 discrimination based on race, color, religion, national origin, sex, sexual orientation, gender identity, age, veteran status, disability, or any other characteristics unrelated to a person’s qualifications or job performance. This commitment extends to all aspects of employment, including recruitment, hiring, job assignments, compensation, training, promotion, demotion, transfers, layoffs, discipline, and separation, as well as all other terms and conditions of employment. /ppRegulatory Market Access Specialist • San Daniele, IT /p #J-18808-Ljbffr

📌 Regulatory Market Access Specialist (Genova)
🏢 LimaCorporate
📍 Genova