Chi siamo
ENOVISTM
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 .
Who We Are
ABOUT ENOVISTM
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

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Di cosa ti occuperai | What You'll Do
Position Summary
:
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
. 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
.
Key
Responsabilities
Handles the preparation and processing of documentation required for new product introductions and
modified




products 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 with
market access team
and 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 Surgical
for the countries under his/her
responsability
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 and
assists
the
Market Access Lead
with 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 advise
of
the impact
to
cross-functional teams.
Develops and
maintains
procedures to ensure compliance and support business goals.
Maintains
proficiency
in government regulations and
guidances
.
Support other regulatory requests or projects as needed.
Preferred
Qualifications




Bachelor's degree with a minimum of 2 years of medical device industry experience
as a Regulatory Specialist
Prior experience with regulatory submissions
for medical devices
in
European and
international markets
General understanding of the product development process and design controls
Ability to manage several projects simultaneously
Strong
interpersonal
and
influencing
skills
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 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.
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.

📌 Regulatory Market Access Specialist (Italia)
🏢 Enovis
📍 Italia