Head of RA-QA/PRRC in Bern

Overview As Head of QA/RA, you will lead the global quality and regulatory affairs function to enable safe, compliant medical devices across multiple markets. You will shape QA/RA strategy, drive continuous improvement, and ensure compliance with EU MDR, FDA, ISO standards, and GMP. You’ll partner with R D, Manufacturing, and external partners to support market access and lifecycle management. This role offers impact at scale in a regulated, international environment and a chance to influence strategy, regulatory submissions, and post-market success. You will be the primary interface with authorities and raise quality and compliance across the organization. Verantwortungsbereiche Lead and develop the global QA/RA function with team management and strategic direction Define and execute QA/RA strategy aligned with business objectives and growth plans Fulfill PRRC responsibilities per EU MDR 2017/745 or ensure compliance Own QMS, audits, CAPA, inspections, and continuous improvement initiatives Ensure compliance with FDA, EU MDR, ISO standards, GMP, and other global regulations Lead regulatory submissions, registrations, changes, lifecycle management across regions Support market expansion and ongoing compliance for existing products Collaborate cross-functionally with R APAC/South America exposure preferred Experience working with CMOs, CDMOs, external manufacturers, and suppliers Medical Device experience in biomaterials, fibers, polymers, coatings, or related products preferred Strong communication, presentation, technical writing, negotiation, and stakeholder management Ability to prioritize and perform in a fast-paced environment Regulatory Affairs, Clinical Research, Clinical Evaluation, or Quality certifications advantageous Entrepreneurial, hands-on mindset with ownership and accountability Fluent English; German and other languages advantageous strong communication stakeholder management negotiation EU MDR (2017/745) FDA 21 CFR Part 820 ISO 13485