Chi 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 www.enovis.com.
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 www.enovis.com
Di cosa ti occuperai | What You'll Do
The Regulatory Market Access Specialist will work in the market access team to bring new andmodifiedmedical devices to market and ensure ongoing compliance. TheRegulatory Market Access Specialistprovides 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 specificEnovisproducts. The Regulatory Market Access Specialist ensures compliance with required regulations andestablishedcorporate standards. The Regulatory Market Access Specialist ensures that product approvals are properlymaintained, and product re-registrations areproperly 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
KeyResponsabilities
Handles the preparation and processing of documentation required for new product introductions andmodifiedproducts in international markets.
Acts as a core team member on sustaining and new product development projects, providing regulatory feedback and guidance throughout the product development cycle.
Works withmarket access teamand cross-functional peers to resolve potential regulatory/technical issues and questions from the regulatory agencies in international markets.
Prepare documentation for international regulatory registrations and licenses
Define regulatory requirements necessary for regulatory approval of Surgicalfor the countries under his/herresponsability
Manages the release and shipment of products under regulatory controls to all regions.
Provides recommendations for how to overcome regulatory barriers and resolve any disputes within teams as to the importance of regulatory requirements.
Coordinates andassiststheMarket Access Leadwith defining regulatory requirements in Regulatory planning process.
Reviews 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.
Maintain all regulatory documentation to ensure availability for external audits and preparation of submission packages
Provides technical guidance and regulatory training to cross-functional teams.
Reviews device labeling and advertising materials for compliance with applicable regulations and recommends appropriate changes.
Monitor the development of new regulatory requirements and adviseofthe impacttocross-functional teams.
Develops andmaintainsprocedures to ensure compliance and support business goals.
Maintainsproficiencyin government regulations andguidances
Support other regulatory requests or projects as needed.
PreferredQualifications
Bachelor’s degree with a minimum of 2 years of medical device industry experienceas a Regulatory Specialist
Prior experience with regulatory submissionsfor medical devicesinEuropean andinternational markets
General understanding of the product development process and design controls
Ability to manage several projects simultaneously
Stronginterpersonalandinfluencingskills
Ability to independently manage projects, prioritize time and communicate effectively
Excellent command of English (spoken and written).
Dichiarazione di pari opportunità
Enovis 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.
Equal Employment Opportunity
At 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.
We’re Enovis™ – a global medical technology innovator dedicated to improving lives by developing clinically differentiated solutions that enhance patient outcomes and restore motion for life.
We strive to make each day better by partnering with the brightest minds in health to advance care that is smarter, personalized, and more effective, while improving operational efficiency for surgeons and clinicians around the world. We do this through our extraordinary talent, a laser focus on innovation, strategic acquisitions, and a common culture of continuous improvement.
With more than 7,000 incredible employees worldwide and an extensive range of products, services, and integrated technologies including recognized brands like DonJoy®, Aircast®, EMPOWR®, MotionMD®, SMR, Ligamys, and DynaNail®, our solutions impact the well-being of millions of patients wherever they are on their pathway to health.
