Regulatory market access specialist

What You’ll Do

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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 Responsibilities

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 products for the countries under his/her responsibility.
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 the 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.
Maintains 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.
Monitors the development of new regulatory requirements and advises on the impact to cross‑functional teams.
Develops and maintains procedures to ensure compliance and support business goals.
Maintains proficiency in government regulations and guidances.
Supports 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 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. xjrgpwk 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
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