Job overview
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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.

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.

Regulatory Affairs Manager (f/m/d)

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

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

  • 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

Ziemer Ophthalmic Systems AG

Allmendstrasse 11

CH-2562 Port, Schweiz

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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