Regulatory Affairs Specialist

Work Flexibility: Hybrid

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 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.

Travel Percentage: 10%