Regulatory Affairs Sustaining Specialist (Medtech)

TL;DR

Regulatory Affairs Sustaining Specialist (Medtech): Managing technical documentation and certifications for medical devices in compliance with MDR regulations with an accent on regulatory change management. Focus on collaborating with cross-functional teams to compile technical files and handling communications with notified bodies.

Location: San Daniele del Friuli, Italy

Company

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

What you will do

• Prepare, update, and manage technical documentation for medical device registration and maintenance according to Regulation (EU) 2017/745 (MDR).
• Collaborate cross-functionally with product development, quality, clinical, and manufacturing teams to compile technical files.
• Manage the regulatory aspects of product and process changes, including reportability assessments and notifications to authorities.
• Handle communications with notified bodies and competent authorities, including responding to deficiency reports.
• Contribute to the definition and improvement of internal regulatory management processes and documentation structures.

Requirements

• Degree in scientific disciplines such as Biology, Chemistry, Biomedical Engineering, or related fields.
• 1–2 years of experience in Regulatory Affairs within the medical device industry.
• Strong knowledge of MDR and major international regulations applicable to medical devices.
• Excellent command of Italian and English (B2/C1 level).
• Proficiency in Microsoft Office, especially Excel.
• Availability for short business trips to Switzerland (2–3 days per quarter).

Culture & Benefits

• Environment driven by a culture of continuous improvement and innovation.
• Opportunity to work within a global team in the medical technology sector.
• Commitment to equal employment opportunities based on merit and qualifications.
• Collaboration within multicultural teams.