Regulatory Market Access Specialist

LimaCorporate S.P.A; San Daniele; On-site; EUR 52,000 - 72,000; Full time

Job summary

Enovis sta cercando uno Regulatory Market Access Specialist per supportare l'ingresso di dispositivi medici nel mercato e garantire la conformità continua. Ruolo chiave nel preparare submission regolatorie e nelle attività di mantenimento della registrazione prodotti a livello internazionale.

Richiesta una laurea in disciplina scientifica/tecnica, almeno 2 anni di esperienza in regolatorio, conoscenza di Excel/Power BI e inglese fluente.

Qualifications

• Laurea in campo scientifico/tecnico richiesto.
• Esperienza in regulatory submissions per dispositivi medicali è preferita.
• Ottima conoscenza dell'inglese (parlato e scritto).

Responsibilities

• Gestire la preparazione e l'elaborazione della documentazione per introduzioni di nuovi prodotti e modifiche in mercati internazionali.
• Far parte del team di sviluppo progetti e fornire feedback regolatori durante il ciclo di sviluppo.
• Collaborare con il team di Market Access e altri reparti per risolvere questioni regolatorie.

Skills

Regulatory affairs

Regulatory submissions

Regulatory compliance

Inglese.

Education

Laurea in disciplina scientifica/tecnica

Tools

Agile PLM

Power BI

Excel

Job description

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.

Who 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 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 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.

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

Preferred Qualifications Bachelor'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 Minimum of 2 years experience of medical device industry as a Regulatory Affairs Specialist Working 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.). Prior experience with regulatory submissions for medical devices in international markets (outside EU) Proficiency in Microsoft Office, especially Excel. 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). Experience using Agile PLM, Power BI, or similar tools is advantageous

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.

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.