Regulatory Affairs Specialist m/w/d (100%)

We are looking for a Regulatory Affairs Specialist m/w/d (100%) immediately or by arrangement. As a Swiss family business with a 160-year history, we employ more than 1600 employees worldwide at SIGVARIS GROUP. With high-quality and innovative offerings in the field of medical compression therapy, we are committed to ensuring that people feel good. Every day. Our portfolio covers a wide variety of needs and indications. Constant development and innovation, as well as a consistent commitment to solutions that support our customers in all their activities, make us the preferred partner for all stakeholders. At SIGVARIS GROUP, we have made it our mission to create an excellent working environment for our most valuable asset, our employees. Because their talents, their diversity, and their commitment are crucial to our innovative strength and our success. In this role, you will contribute to ensuring the regulatory compliance of our medical devices and creating the necessary requirements for their development, manufacture, marketing, and distribution on a national and international level. In doing so, you will support the continuous further development of our quality management system and accompany our products throughout their entire regulatory lifecycle. These are your tasks: * Maintenance, further development, and implementation of the quality management system according to ISO 13485 * Creation and approval of quality and regulatory documents as well as technical documentation according to MDR (EU) 2017/745 * Planning and accompanying internal and external audits, inspections, and conformity assessments * Vigilance, Post-Market Surveillance, product registrations, and regulatory review of product changes * Support in risk, CAPA, and deviation management as well as advising internal stakeholders and contacting authorities and Notified Bodies What you bring with you: * Completed training or Bachelor's degree in medical technology, natural sciences, engineering, quality management, or comparable * Initial experience or internships in quality management, regulatory affairs, or a regulated environment * Basic knowledge of ISO 13485 and MDR as well as experience with technical or quality-relevant documents * Fluent German and English skills in spoken and written language; confident handling of MS Office; experience with document or QMS systems is an advantage * Careful and reliable way of working, willingness to learn, quality awareness, and strong communication skills Our offer: * To be part of an international company and to contribute to people feeling well through varied tasks. Every day. * Independent work with plenty of room for personal and professional development * Stable family business with high market and value orientation * Competitive salary & benefits as well as very good insurance benefits * Flexible working model, including home office possibility Are you interested in this exciting job? Then send us your application documents. [Apply now](< >) SIGVARIS AG - Gröblistrasse 8 - 9014 St. Gallen j4id10430147jm j4it1041jm j4iy26jm