Regulatory Affairs and Compliance Specialist | Regulatory Affairs / Compliance

Job Summary

This role is essential for ensuring Samaplast AG, a specialized manufacturer of high-quality plastic medical devices for over 60 years, maintains strict adherence to regulatory standards and corporate social responsibility (CSR). You will be the primary contact for all Regulatory Affairs and Compliance issues, both internally and externally, focusing heavily on medical device requirements. Key responsibilities include monitoring and implementing regulatory changes, managing documentation, and acting as the main point of contact for project-related compliance questions. A significant part of the job involves preparing for and conducting internal and external audits, overseeing processes for product cleanliness and sterility, and leading annual staff training sessions on compliance topics. This is an attractive opportunity within a future-oriented MedTech company, offering challenging and varied projects, a highly modern workplace with the newest IT infrastructure, flexible working hours including home office options, and generous holiday allowance (28 days).