Senior Regulatory Affairs Manager 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.

Tasks

Responsibility for planning, implementing, and maintaining regulatory strategies for medical devices in international markets
Ensuring compliance with all relevant regulatory requirements throughout the entire product lifecycle, including maintenance of Technical Files
Preparation, review, and maintenance of regulatory documentation and submission dossiers
Support with regulatory authority inquiries, audits, and inspections, as well as communication with notified bodies and authorities
Providing professional advice and support to internal stakeholders on regulatory matters
Close collaboration with Quality, Clinical, R&D, and other functions to ensure regulatory requirements are met during development and change processes
Continuous monitoring of regulatory developments in the field and deriving actions for the company
Actively supporting and developing the Regulatory Affairs team through knowledge sharing, coaching, and best-practice exchange

We offer you an exciting challenge in a growth-oriented medical technology market. As a dedicated and proactive individual, you will have the opportunity to actively shape the future of our dynamic company.

Profile

Completed university degree in a relevant field (e.g., Medical Technology, Life Sciences, Biomedical Sciences, or equivalent)
Minimum of 5 years of experience in Regulatory Affairs within the medical device industry
Proven experience with EU MDR requirements, FDA registration processes, and international medical device regulations
Proactive work style with a high level of personal responsibility
Ability to share knowledge and act as a professional point of contact within the team
Strong team player with excellent interpersonal skills
Open personality with enthusiasm for interdisciplinary collaboration
Organizational talent and the ability to prioritize in a dynamic environment
Solution-oriented thinking, strong quality awareness, and precise working style
Excellent verbal and written communication skills in English and German

For further information, please contact Mr. Richard Büchi, Director Human Resources, richard.buechi@ziemergroup.com or +41 32 332 71 00. For technical questions, please reach out to Dr. Michela Peisino, Director Regulatory Affairs, michela.peisino@ziemergroup.com.

Ziemer Ophthalmic Systems AG

Allmendstrasse 11

CH-2562 Port

Switzerland