Regulatory Affairs Specialist page is loaded## Regulatory Affairs Specialistlocations: Biberist, Switzerlandtime type: Full timeposted on: Posted Todayjob requisition id: R561546Work 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%
#J-18808-Ljbffr