Welcome to our team in Mannheim, where we're shaping the future of healthcare together! For our client in the medical technology sector, we're looking for a dedicated Technical Study Coordinator (m/f/d) who impresses with their expertise and precision. If you're fascinated by the interface between technology and regulatory affairs, we look forward to receiving your application!
Here's what we offer
1. Attractive salary and long-term job security through affiliation with a large corporation.
2. Up to 30 days of vacation per year
3. Company pension scheme contribution after the end of the probationary period
4. Extensive social benefits, including Christmas and holiday pay
Your tasks
5. They are responsible for creating and reviewing the technical documentation for clinical trials in accordance with regulatory requirements.
6. They coordinate the collaboration of internal departments and create schedules for study samples and prototypes.
7. They provide technical input for clinical development plans and finalize the study strategy in close coordination with the Medical Lead.
8. They assess the technical documentation for consistency and suitability for reuse based on previous studies.
9. They act as internal advisors for relevant regulations such as MDR, CFR 21 and the MPDG.
Your profile
10. Completed studies in a scientific-technical or medical-technical field.
11. Solid professional experience in medical technology or a highly regulated environment.
12. Sound knowledge of clinical trial approval, MDR, and product risk assessment.
13. Practical experience in direct collaboration with regulatory authorities.
14. Language skills: Fluent German and English skills (spoken and written).