Clinical & Regulatory Affairs Compliance Coordinator

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

• Preparation of clinical evaluations for Class I, IIa, IIb, and IIb implantable products
• Ensuring compliance with all regulatory requirements relating to products and their documentation
• Coordination of the maintenance of all MDR tech files and clinical evaluations (pre-market, post-market, and product changes)
• Carrying out project work in consultation with the supervisor
• Active cooperation with internal and external specialists
• Central interface to the PMS, PMCF, literature search and clinical investigation processes
• Supporting and moderating strategic discussions in the CA & RA environment

Profile

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.