We Deliver Vision To The World
We aim to enhance the lives of millions. Driven by our passion for innovation, we tirelessly develop cutting-edge products and services in ophthalmology. Become a part of the Ziemer Group's 25-year legacy and contribute to our ever-expanding team.
As Clinical & Regulatory Affairs Compliance Coordinator, you will play a key role in ensuring regulatory compliance and clinical evaluation of our medical technology products. You will act as the operational process owner for clinical evaluation and make a significant contribution to the further development of internal expertise in the area of clinical & regulatory affairs.
Tasks
1. Preparation of clinical evaluations for Class I, IIa, IIb, and IIb implantable products
2. Ensuring compliance with all regulatory requirements relating to products and their documentation
3. Coordination of the maintenance of all MDR tech files and clinical evaluations (pre-market, post-market, and product changes)
4. Carrying out project work in consultation with the supervisor
5. Active cooperation with internal and external specialists
6. Central interface to the PMS, PMCF, literature search and clinical investigation processes
7. Supporting and moderating strategic discussions in the CA & RA environment
Profile
8. Technical university degree (university or university of applied sciences)
9. Several years of experience in clinical AND regulatory affairs in medical technology
10. Ideally, experience with FDA registration processes
11. Sound knowledge of MS Office
12. Very good German and English skills, other languages are an advantage
13. Analytical and conceptual thinking skills
14. Structured, independent and precise way of working
15. Communicative, open personality with a passion for interdisciplinary collaboration
We offer you an exciting challenge in the growth-oriented medical technology market. As a committed and proactive personality, you can help shape the future of our dynamic company.