As a RAQA Specialist, you will support Regulatory Affairs and Quality activities across Germany, Switzerland, and Austria with a strong focus on Swiss registration requirements
Job Summary
As a RAQA Specialist, you will support Regulatory Affairs and Quality activities across Germany, Switzerland, and Austria with a strong focus on Swiss registration requirements.
You will help ensure compliance with MDR 2017/745 and applicable Swiss legislation, drive product registration and maintenance activities, and support continuous improvement of Quality Management System processes.
Collaborating with cross-functional stakeholders and global teams, you will contribute to a compliant, efficient, and continuously improving RAQA organization.
Matching Summary
As a RAQA Specialist, you will support Regulatory Affairs and Quality activities across Germany, Switzerland, and Austria with a strong focus on Swiss registration requirements.
Skills & Requirements
Must-have
Regulatory submissions and registrations
Quality Management System process support
Swiss regulatory applications and compliance
MDR 2017/745 compliance
Cross-functional collaboration
Bilingual English and German communication
Nice-to-have
Continuous improvement mindset
Stakeholder management skills
Experience with Swissdamed system
Audit and inspection readiness support
Knowledge of Swiss market requirements
Key Requirements
Bachelor's degree in Engineering or Science
2+ years Regulatory Affairs & Quality Assurance experience
Proficiency in English and German
Knowledge of MDR 2017/745 and Swiss MedDO
Experience with regulatory submissions and QMS documentation