About this role
About the Role Integrated into the site's Vigilance team (3 people), the Specialist Materiovigilance role focuses on processing customer complaints, coordinating investigations, and preparing regulatory reports to ensure compliance across Europe and the US. We manufacture long-term Class 3 medical devices with active substances and animal-origin derivatives. What You'll Do
- Participate in the treatment of customer complaints for products manufactured in accordance with current requirements
- Coordinate investigations (collaboration with Quality, management of studies with external analysis laboratories)
- Prepare Europe MIR and US MDR regulatory reports within deadlines
- Analyze and monitor trends
- Participate in drafting annual Post-Market Surveillance reports for different product ranges
- Provide support for the preparation/coordination of product recalls and communications to authorities
- Maintain and contribute to evolution of the procedures related to the activity What We're Looking For
- Degree from an engineering school or Bac+5 in Biomedical Engineering, Pharmacy, Health Engineering or Quality
- At least 3 years of experience in complaint handling, ideally in medical devices
- Strong knowledge of medical device regulations (EU MDR 2017-745, MDSAP, MEDDEV2.12, 21 CFR) and ISO 13485:2016
- Professional-level English (written and spoken)
- Proficiency with office tools
- Strong analytical mindset and ability to work in a demanding environment with a complex product range