Head of Regulatory Affairs & Quality Management System m/f/d

We are looking for a Head of Regulatory Affairs & Quality Management m/f/d starting 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. These are your tasks * Functional and personnel leadership as well as further development of the local Regulatory Affairs team * Ensuring regulatory compliance throughout the entire product lifecycle of our international medical device portfolio * Development of regulatory strategies for new products, product changes, and lifecycle management including technical documentation * Ensuring compliance with the EU Medical Device Regulation (MDR 2017/745) as well as other relevant international regulatory requirements * Responsibility for the Quality Management System, the conduct of internal and external audits, as well as the continuous optimization of regulatory processes and systems (ISO 13485) * Responsibility for international product registrations and market authorizations including conformity documentation * Representation of the company towards Notified Bodies, authorities, and international regulatory institutions * Close cooperation with the departments Product Management, R&D, Quality Assurance, Operations, Marketing, and Sales * Support in the development and implementation of a global Regulatory Affairs strategy in cooperation with the global Quality & Regulatory team * Observation of regulatory developments and implementation of new requirements into processes and product strategies in cooperation with the global Quality & Regulatory team Your profile * Completed university degree in natural sciences, medical technology, biomedicine, pharmacy, or a comparable field * Several years of professional experience in the field of Regulatory Affairs for medical devices -- experience with textile medical devices (clinical textiles, wound healing, orthopedics, ...) is an advantage * Proven leadership experience in an international corporate environment as well as enjoyment in developing high-performance teams * Sound knowledge of the EU Medical Device Regulation (MDR 2017/745) is a prerequisite * Experience in leading complex international authorization and registration projects * Strategic thinking skills, entrepreneurial action, as well as a structured and solution-oriented way of working * Strong communication and stakeholder management skills as well as the ability to collaborate successfully at all levels of an international company * Business fluent English skills; other foreign languages are an advantage What we offer to you * A strategic leadership position with high visibility within the corporate group * The opportunity to actively help shape the regulatory future of an internationally successful medical technology company * An innovative, appreciative, and international working environment with short decision-making paths * Cooperation with dedicated experts worldwide * Attractive employment conditions as well as diverse opportunities for professional and personal development Do you have sound experience in the field of Regulatory Affairs for medical devices, know the requirements of the EU MDR and international authorization procedures, and want to shape regulatory excellence together in a global team? Then we look forward to getting to know you. Are you interested in this exciting job? Then send us your application documents. [Apply now](< >) SIGVARIS AG - Gröblistrasse 8 - 9014 St. Gallen j4id10438446jm j4it1042jm j4iy26jm