Overview As Head of Regulatory Affairs, you steer the global regulatory strategy for Ypsomed’s drug–device and medical devices, enabling safe and timely market access. You will lead the Regulatory Affairs team and partner with R D, Quality, Manufacturing, and Commercial to embed regulatory excellence into design and execution. You address complex regulatory challenges, oversee submissions and lifecycle management, and act as the senior liaison with authorities and notified bodies. This role shapes our innovation journey while upholding high compliance and quality standards. Verantwortungsbereiche Define and lead global regulatory strategy for drug–device and medical devices in line with business goals Oversee end-to-end regulatory lifecycle management: development support, initial approvals (EU MDR, FDA, key Asian markets), variations, renewals, and post-market obligations Lead and develop the Regulatory Affairs team (planning, performance management, capability building) and act as escalation point for complex issues Ensure timely, high-quality regulatory submissions and dossiers (EU MDR technical documentation, FDA 510(k)) Serve as primary interface with regulatory authorities, notified bodies, and external partners; manage inspections and CAPA programs Partner with R Asia a plus) Proven leadership experience building and managing high-performing RA teams with senior-level influence Deep hands-on expertise in EU MDR technical documentation and FDA submissions (510(k)); solid understanding of QMS ISO 13485 and design controls Bachelor in Life Sciences; advanced degree or RA certifications are a plus Excellent strategic thinking, problem-solving, and communication skills in English (C1); German (B2) advantageous for Swiss interactions Strategic thinking Problem-solving Communication EU MDR technical documentation FDA submissions (510(k)) QMS ISO 13485
Head of Regulatory Affairs in Burgdorf Arbeitgeber: Ypsomed
Ypsomed ist ein hervorragender Arbeitgeber, der eine offene und inklusive Unternehmenskultur fördert, in der Vielfalt geschätzt wird. Unsere Mitarbeitenden profitieren von einer modernen Arbeitsumgebung in Solothurn, attraktiven Benefits wie einer finanziellen Beteiligung an der Kinderbetreuung und kostenlosen Sportanlagen sowie vielfältigen Möglichkeiten zur persönlichen und beruflichen Weiterentwicklung. Hier gestalten Sie nicht nur Veranstaltungen, sondern tragen aktiv zur Verbesserung der Lebensqualität von Menschen mit chronischen Krankheiten bei.
