Regulatory market access specialist

Ph3What You’ll Do /h3 h3Position Summary /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. The 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 Responsibilities /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 products for the countries under his/her responsibility. /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 the 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 liMaintains 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 liMonitors the development of new regulatory requirements and advises on 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. /li liSupports other regulatory requests or projects as needed. /li /ul h3Preferred Qualifications /h3 ul liBachelor’s degree with a minimum of 2 years of medical device industry experience as a Regulatory Specialist. /li liPrior experience with regulatory submissions for medical devices in European and international markets. /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 independently manage projects, prioritize time and communicate effectively. /li liExcellent command of English (spoken and written). /li /ul h3Dichiarazione di pari opportunità /h3 pEnovis si impegna a garantire pari opportunità 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. /p h3Equal Employment Opportunity /h3 /p #J-18808-Ljbffr