Employee Quality Management & Regulatory Affairs

Employee Quality Management & Regulatory Affairs (QM/RA) (m/f/d) Employee Quality Management & Regulatory Affairs (QM/RA) (m/f/d) RUWAG Handels AG, based in Bettlach (Solothurn), was founded in 1987. As a distributor of in-vitro diagnostics (IVD), laboratory equipment, consumables, and life science products, we supply medical laboratories, hospitals, universities, and research institutes. We are part of the Calibre Scientific Group, a diversified, global life science company that aims to support scientists by providing high-quality products and services. At our location in Bettlach, we currently employ around 35 employees. To strengthen our team and support the management of QM&RA, we are looking for a committed personality in the field of quality management and regulatory affairs at the earliest possible date. Your tasks You report to the management of QM&RA and support them in all relevant processes in the areas of QM and RA: Quality Management Maintenance and further development of the electronic quality management system Maintenance and updating of QM documents, processes, and work instructions Operational processing of deviations, complaints, corrective and preventive actions (CAPA) Participation in change management and risk management processes Participation in the analysis, assessment, and implementation of suggestions in the continuous improvement process Support in the planning, execution, and follow-up of internal audits Support in external audits and authority inspections Training of employees in quality-relevant topics General administrative activities in the QM area Regulatory Affairs Ensuring the regulatory compliance of the distributed products according to IvDV, MepV, and other relevant regulations Administration and maintenance of technical and regulatory documentation Examination of manufacturer documents and declarations of conformity Support with product registrations and reporting obligations to authorities Processing of vigilance and post-market surveillance processes in cooperation with the RA management and manufacturers Contact person for internal departments on regulatory issues Your profile Completed studies or training in the field of medical technology, life sciences, pharmacy, natural sciences, law/economics, or other comparable qualifications At least 1-2 years of professional experience in quality management and/or regulatory affairs Knowledge of relevant standards and regulatory requirements (e.g., ISO 9001:, IvDv and MepV and other international standards) Structured, precise, and independent way of working Strong service orientation and high willingness to work in a team Analytical thinking and high quality orientation Very good German and English skills, French skills are an advantage Confident handling of MS Office applications We offer Varied activity with responsible tasks Collegial working environment with high professional competence Flat hierarchies and short decision-making paths Further training and development opportunities Modern office spaces Have we aroused your interest? Then we look forward to receiving your complete application documents, stating your earliest possible starting date and your salary expectations. jpidb6159d1jm jit0832jm jiy26jm