Regulatory Affairs Sustaining Specialist (Medtech)

TL;DR

Regulatory Affairs Sustaining Specialist (Medtech): Managing and updating technical documentation for medical device certifications according to MDR regulations with an accent on change management and compliance. Focus on coordinating with cross-functional teams and communicating with notified bodies to ensure certification maintenance.

Location: San Daniele del Friuli, Italy. Availability for short business trips to Switzerland (2-3 days per quarter) is required.

Company

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

What you will do

• Prepare and manage technical documentation for medical device registration and maintenance in accordance with Regulation (EU) 2017/745 (MDR).
• Collaborate cross-functionally with product development, quality, clinical, and manufacturing teams to compile technical files.
• Manage regulatory aspects of product and process changes, including reportability assessments and notifications to competent authorities.
• Handle direct communications with notified bodies and prepare responses to deficiency reports or requests for clarification.
• 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 specifically 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, with a particular emphasis on Excel.
• Availability for short business trips to Switzerland (2–3 days per quarter).

Culture & Benefits

• Opportunity to work within a global, innovation-driven medical technology environment.
• Culture centered on continuous improvement and collaboration among global talent.
• Commitment to equal employment opportunity based on merit and qualifications.