Job Title: 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 the 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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