Regulatory Market Access Specialist (Medtech)

TL;DR

Regulatory Market Access Specialist (Medtech): Managing the introduction and compliance of new and modified medical devices in international markets with an accent on regulatory submissions and market access strategies. Focus on overcoming regulatory barriers, coordinating cross-functional approvals, and ensuring ongoing compliance with global standards.

Location: San Daniele del Friuli, Italy

Company

hirify.global is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions in orthopedics and beyond.

What you will do

• Prepare and process documentation required for new product introductions and modified products in international markets.
• Provide regulatory feedback and guidance as a core team member on sustaining and new product development projects.
• Collaborate with the market access team and cross-functional peers to resolve regulatory and technical issues from international agencies.
• Define and document regulatory requirements necessary for surgical product approvals in assigned countries.
• Manage the release and shipment of products under regulatory controls across all regions.
• Review device labeling and advertising materials to ensure compliance with applicable regulations.

Requirements

• Bachelor’s degree with at least 2 years of experience as a Regulatory Specialist in the medical device industry.
• Proven experience with regulatory submissions for medical devices in European and international markets.
• General understanding of the product development process and design controls.
• Ability to independently manage multiple projects, prioritize time, and communicate effectively.
• Excellent command of English (spoken and written).
• Must be based in San Daniele del Friuli, Italy.

Culture & Benefits

• Commitment to equal employment opportunity based on merit and qualifications.
• Culture of continuous improvement and global talent innovation.
• Opportunity to work in a growth-oriented medical technology environment.