Ziemer Ophthalmic Systems AG
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Regulatory Affairs Manager (f/m/d) 80-100%

High-Tech. Family-focused. 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.

Why Ziemer

In this exciting and responsible position, you will be responsible for the worldwide registration of high-tech ophthalmic medical devices and the coordination of RA-related technical documentation.

Tasks

  • Development of strategies for global product registration and clinical trials
  • Responsible for regulatory activities, coordination of internal departments
  • Monitor and report on regulatory changes and best practices in assigned countries
  • Establish and maintain relationships between company, distributors and authorities
  • Creating and updating internal standard operating procedures and technical documents

Profile

  • University degree in the (bio)medical field
  • Ideally further training in quality management and/or regulatory affairs
  • Experience with quality management systems for medical devices (ISO13485, 21CFR820, MDD 93/42/EEC, MDR 2017/745(EU))
  • Practical experience in regulatory affairs and registration of medical devices
  • Experience in project management in medical technology is an advantage
  • Advanced knowledge of MS Office
  • Business fluent in English, good knowledge of German (B2 or higher) an advantage
  • High self-motivation, ability to work in a team, detail orientation and very good planning/time management skills
  • Networked thinking, flair for interdisciplinary work and flexibility

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.

For further information, please contact Mr. Richard Büchi, Director Human Resources, richard.buechi@ziemergroup.com or phone 032 332 71 00.

For technical questions, please contact Dr. Michela Peisino, Director Quality Management & Regulatory Affairs, phone 032 332 71 53.

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