Regulatory Market Access Specialist

h3Chi siamo /h3 h3ENOVIS™ /h3 pEnovis 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 al 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 /p h3Who We Are /h3 h3ABOUT ENOVIS™ /h3 pEnovis 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 /p h3Di cosa ti occuperai |

What You'll Do
/h3 pThe 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. /p h3Key Responsabilities /h3 ul liHandles the preparation and processing of documentation required for new product introductions and modified products in international markets. /li liActs as a core team member on sustaining and new product development projects, providing regulatory feedback and guidance throughout the product development cycle. /li liWorks with market access team and cross‑functional peers to resolve potential regulatory/technical issues and questions from the regulatory agencies in international markets. /li liPrepare documentation for international regulatory registrations and licenses /li liDefine regulatory requirements necessary for regulatory approval of Surgical for the countries under his/her responsability /li liManages the release and shipment of products under regulatory controls to all regions. /li liProvides recommendations for how to overcome regulatory barriers and resolve any disputes within teams as to the importance of regulatory requirements. /li liCoordinates and assists the Market Access Lead with defining regulatory requirements in Regulatory planning process. /li liReviews 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. /li liMaintain all regulatory documentation to ensure availability for external audits and preparation of submission packages /li liProvides technical guidance and regulatory training to cross‑functional teams. /li liReviews device labeling and advertising materials for compliance with applicable regulations and recommends appropriate changes. /li liMonitor the development of new regulatory requirements and advise of the impact to cross‑functional teams. /li liDevelops and maintains procedures to ensure compliance and support business goals. /li liMaintains proficiency in government regulations and guidances. /liliSupport other regulatory requests or projects as needed. /li /ul h3Preferred Qualifications /h3 ul liBachelor'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).z /li liMinimum of 2 years experience of medical device industry as a Regulatory Affairs Specialist /li liWorking 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.). /li liPrior experience with regulatory submissions for medical devices in international markets (outside EU) /li liProficiency in Microsoft Office, especially Excel. /li liGeneral understanding of the product development process and design controls /li liAbility to manage several projects simultaneously /li liStrong interpersonal and influencing skills /li liAbility to independ