Junior Regulatory Product Maintenance specialist
Orthofix · Bussolengo
RegulatoryFull-timeCompany career page
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Role summary
Orthofix seeks a Junior Regulatory Product Maintenance Specialist for their Regulatory Affairs team in Verona, Italy. This one-year temporary role maintains and updates product technical documentation files to ensure compliance with international regulatory requirements and timely submission deadlines.
What they're looking for
- Technical degree
- One year experience in similar role at medical device company
- Fluent English and Italian, written and oral
- Knowledge of EU MDR and medical device regulations
- Technical knowledge of medical devices and manufacturing processes
- Strong organizational skills and attention to detail
What you'll be doing
- Update and maintain regulatory technical documentation in product Technical Files and FDA applications
- Prepare and maintain current Procedure Pack Files and product technical sheets in Italian and English
- Interface with notified bodies and internal departments on technical documentation updates
- Support regulatory team in daily activities and international registration documentation requests
- Support product leaflets, labeling, and IFU maintenance and regulatory document changes
Compensation€30,000–€35,000 annual
Privacy & handoff
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