Vice President Quality & Regulatory

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.

As Vice President Quality & Regulatory, you will have overall responsibility for quality management and the approval of our medical technology products. You will ensure that our company complies with the highest regulatory standards both nationally and internationally (including ISO 13485, FDA 21 CFR 820, EUR-MDR 2017 / 745 Medical Device Regulation). At the same time, as a member of the management team, you will shape the further development of our organization and strengthen our position as a reliable partner for doctors and patients worldwide.

Tasks

• Strategic and operational management of quality management and regulatory affairs
• Responsibility for the further development and audit security of the quality management system (including MDSAP)
• Operational implementation of internal audits and supplier audits in accordance with ISO 13485, MDR, and MDSAP
• Assumption of the role of Person Responsible for Regulatory Compliance (PRRC) in accordance with EU MDR
• Management of approval processes and communication with notified bodies and authorities
• Ensuring product conformity and product approval
• Leadership, promotion, and further development of subordinate teams
• Close cooperation with the CEO, management, and internal stakeholders

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.