RAQA Specialist (m/f/d) – Regulatory Affairs & Quality Systems
Job Summary: As a RAQA Specialist, you will support Regulatory Affairs and Quality activities for our business across Germany, Switzerland, and Austria (GSA), with a strong focus on Swiss registration requirements. You will help ensure compliance with MDR 2017/745 and applicable Swiss legislation (e.g., MedDO), drive product registration and maintenance activities (including Swissmedic/Swiss regulatory applications such as Swissdamed), and support continuous improvement of Quality Management System (QMS) processes. Collaborating with cross‑functional stakeholders and global teams, you will contribute to a compliant, efficient, and continuously improving RAQA organization.
What will you do
Support product registration and lifecycle maintenance activities for Switzerland (and GSA as applicable), including preparation, review, and maintenance of regulatory documentation and registrations.
Coordinate and support Swiss regulatory submissions/notifications and system activities (e.g., Swissdamed and related Swissmedic applications), ensuring data quality, completeness, and compliance.
Support the monitoring of regulatory requirements (MDR and Swiss MedDO) and support impact assessments and implementation of changes.
Provide day‑to‑day RAQA process support to internal stakeholders (e.g., Supply Chain, Customer Service, Technical Service, Commercial), including guidance on local regulatory requirements.
Support QMS processes and documentation (e.g., SOP updates, records management, training support) and contribute to continuous improvement initiatives.
Support internal and external audits and inspection readiness activities related to RA/QA topics.
Contribute to cross‑functional projects and governance initiatives to strengthen RAQA processes and interfaces.
What will you need
Required
Bachelor's degree in Engineering, Science, or a related field. Master’s is a plus.
2+ years of experience in Regulatory Affairs & Quality Assurance (RAQA) or a related role in a medical device, pharmaceutical, or other highly regulated industry.
Practical experience in one or more of the following areas is preferred: regulatory submissions/registrations, product registration maintenance, QMS process support, change control documentation, or regulatory compliance activities.
Proficiency in English and German, with strong communication and collaboration skills.
Preferred
Knowledge of MDR 2017/745 and Swiss medical device legislation (e.g., MedDO), and an understanding of Swiss market requirements (e.g., CH-REP/Swiss registration concepts).
Experience with Swiss regulatory tools/systems (e.g., Swissdamed) or comparable registration databases and data maintenance activities.
Experience supporting QMS documentation processes (e.g., SOP changes, training deployment, audit support).
Confident stakeholder management skills and a continuous improvement mindset.
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