The Opportunity
This position works out of our Wiesbaden-Delkenheim Abbott GmbH location
We are seeking for a Vigilance Specialist for IVDs & Medical Devices (m/f/d)Your Tasks
1. Vigilance and post-market surveillance activities in compliance with international regulatory requirements for in-vitro diagnostics and medical devices specifically for Core Diagnostics and Molecular Diagnostics products from Abbott, focusing on the European Economic Area, Switzerland, and Great Britain.
2. Incident report review and submission to relevant authorities and notified bodies
3. Preparation of Field Safety Corrective Action reports and Trends reports based on manufacturer-provided information and reporting to authorities
4. Handling of authority inquiries within specified deadlines by compiling and consolidating information from various departments.
5. Monitoring current vigilance legislation, especially within the European Economic Area.
6. Participation in or leading projects related to vigilance/post-market surveillance processes.
Your Profile
7. Strong academic background in a scientific discipline (e.g., life sciences, medicine, pharmacy); advanced degrees (Diploma, PhD) are advantageous.
8. Experience in In-Vitro Diagnostics, Medical Devices, and/or the Pharmaceutical industry.
9. Additional expertise in pharmacovigilance, regulatory affairs, or vigilance within medical technology industry is a plus
10. Proven ability to work in international environments or on global projects; international work experience is a plus.
11. Proficiency in English (fluent) and German (very good); additional European languages are beneficial.
12. Competent in using PC-based applications and digital tools.
13. Excellent communication and negotiation skills.
14. Cultural sensitivity and a collaborative team-oriented mindset.