Clinical & Regulatory Affairs Compliance Coordinator 80-100%

High-tech. Family-oriented. Global.

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

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.

Have we aroused your interest? Then we look forward to receiving your complete online application.

Profile

Technical university degree (university or university of applied sciences)
Several years of experience in clinical AND regulatory affairs in medical technology
Ideally, experience with FDA registration processes
Sound knowledge of MS Office
Very good German and English skills, other languages are an advantage
Analytical and conceptual thinking skills
Structured, independent and precise way of working
Communicative, open personality with a passion for interdisciplinary collaboration

Ziemer Ophthalmic Systems AG

Allmendstrasse 11

CH-2562 Port, Switzerland

For further information, please contact Mr. Richard Büchi, Director Human Resources, richard.buechi@ziemergroup.com or +41 32 332 71 00. If you have any technical questions, please contact Ms. Michela Peisino, Director Regulatory Affairs, michela.peisino@ziemergroup.com.

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