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Clinical & Regulatory Affairs Compliance Coordinator
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Clinical & Regulatory Affairs Compliance Coordinator
Ziemer Ophthalmic Systems AGPort, Bern, SwitzerlandWe 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.