Regulatory Market Access Specialist

Responsibilities

• Prepare and process documentation required for new product introductions and modified products in international markets
• Act as a core team member on sustaining and new product development projects, providing regulatory guidance throughout the lifecycle
• Prepare documentation for international regulatory registrations and licenses
• Define regulatory requirements necessary for product approval in assigned countries
• Review and approve design and manufacturing changes for existing products to ensure compliance
• Maintain all regulatory documentation to ensure availability for external audits and submission packages
• Review device labeling and advertising materials for compliance with applicable regulations
• Monitor the development of new regulatory requirements and advise cross-functional teams of the impact
• Manage the release and shipment of products under regulatory controls to all regions

Requirements

• Bachelor’s degree
• Minimum of 2 years of medical device industry experience as a Regulatory Specialist
• Experience with international regulatory submissions
• Understanding of product development processes and design controls
• Excellent command of English (spoken and written)

Preferred Qualifications

• Prior experience with regulatory submissions for medical devices in European and international markets
• Ability to manage several projects simultaneously
• Strong interpersonal and influencing skills
• Ability to independently manage projects, prioritize time, and communicate effectively

About the Company

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.