Ziemer Ophthalmic Systems AG
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Senior Clinical Affairs Manager 80-100%

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.

Why Ziemer

As Senior Clinical Affairs Manager, you take on a central role in the clinical evaluation and strategic direction of our medical devices across the entire product lifecycle. You bring deep clinical expertise, independently drive Clinical Evaluation Reports and PMCF activities, and collaborate closely with cross-functional departments such as Regulatory Affairs, R&D, Quality and Marketing. Beyond your technical strength, you are a confident, assertive personality who takes clear positions, supports colleagues professionally, and actively contributes to the development of the team.

Tasks

  • Development and implementation of the clinical strategy for the entire product portfolio
  • Creation, review and maintenance of Clinical Evaluation Reports (CER) in accordance with MEDDEV 2.7/1 Rev. 4 and MDR Annex XIV
  • Conduct of systematic literature searches and critical appraisal of clinical evidence and state-of-the-art analyses
  • Independent planning and execution of Post-Market Clinical Follow-up (PMCF) activities including PMCF Plan and PMCF Evaluation Report
  • Authoring and review of clinical study protocols according to ISO 14155 and GCP
  • Close collaboration with Regulatory Affairs in the creation and maintenance of technical documentation (Technical Files)
  • Clinical input for PMS processes, PSURs, and support of regulatory submissions and communication with Notified Bodies
  • Professional guidance and mentoring of junior team members and active knowledge sharing within the team
  • Independent representation of clinical positions towards management, Notified Bodies and regulatory authorities

Profile

  • Degree in medical engineering, natural sciences or a comparable field (Master's or higher preferred)
  • Minimum 5 years of relevant experience in Clinical Affairs within the medical device industry
  • Proven expertise in independently authoring Clinical Evaluation Reports (CERs) and Clinical Evaluation Plans (CEPs)
  • Sound knowledge of PMCF planning and execution in accordance with the MDR
  • Experience in authoring clinical study protocols according to ISO 14155 and GCP
  • Familiarity with Technical Files / technical documentation under the MDR; knowledge of additional regulatory markets (FDA, Health Canada, etc.) is an advantage
  • Strong knowledge of EU MDR 2017/745 and relevant standards (ISO 14155, ISO 14971, MEDDEV guidelines)
  • Experience working with Notified Bodies as well as audits and technical reviews
  • Confident, assertive personality with a proactive approach and a high sense of personal responsibility
  • Ability to share knowledge and act as a subject matter expert within the team
  • Strong team player with high social competence; open personality who enjoys interdisciplinary collaboration
  • High quality awareness, analytical strength and a pronounced scientific mindset
  • Strong organizational skills and ability to prioritize in a dynamic environment
  • Solution-oriented thinking, precise and structured way of working

 

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, Human Resources, or +41 32 332 71 00. If you have any technical questions, please contact Ms. Claudia De Santis, Vice President Quality Management & Regulatory Affairs,

Ziemer Ophthalmic Systems AG
Allmendstrasse 11
CH-2562 Port, Switzerland

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