Head of Regulatory Affairs

Define and lead Ypsomed’s global regulatory strategy for drug–device combination products and medical devices, ensuring alignment with business goals and innovation roadmaps. Oversee end-to-end regulatory lifecycle management: development support, initial approvals (EU MDR, FDA, and key Asian markets), variations, renewals, and post-market regulatory obligations. Lead and develop the Regulatory Affairs team (activity planning, goal setting, performance management, capability building) and act as the senior escalation point for complex regulatory issues. Ensure timely, high-quality regulatory submissions and dossiers (e.g., EU technical documentation under MDR, FDA 510(k)). Serve as primary interface with regulatory authorities, notified bodies, and external partners; manage inspections/audits and drive corrective and preventive actions to maintain compliance. Partner closely with R&D;, Quality, Manufacturing, Clinical, Marketing, and Commercial to embed regulatory requirements early in design controls, risk management (ISO 14971), and change management processes. Monitor and interpret evolving regulations and guidance (EU MDR, FDA QMSR, Swiss MedDO, MDSAP, cybersecurity/AI-related expectations) and translate them into actionable strategies and SOP. Drive continuous improvement of regulatory processes, templates, and tools (including digital/automation opportunities) to increase speed, consistency, and audit readiness across the product portfolio.

Ypsomed is a leading Swiss medical technology company specializing in innovative injection systems for drug delivery. Headquartered in Burgdorf, Switzerland, the company combines decades of expertise in drug-device combination products and medical devices with a global footprint, serving pharma (partners or customers) and patients worldwide. Ypsomed is committed to improving patient outcomes through user-centric design, regulatory excellence, and sustainable manufacturing practices.

• University degree in Life Sciences, Biomedical/Medical Engineering, Pharmacy, or a related field; advanced degree or RA-specific certifications are a plus

• 10+ years of progressive Regulatory Affairs experience in medical devices in the B2B sector, with substantial exposure to drug–device combination products and global markets (EU, US, Switzerland; Asia is a plus) and GMP/Pharma experience is advantageous

• Proven leadership experience building and managing high-performing RA teams, with strong stakeholder influence at senior management level

• Deep, hands-on expertise in EU MDR technical documentation, FDA submissions (e.g., 510(k)), solid understanding of QMS (ISO 13485) and design controls

• Excellent strategic thinking, problem-solving, and communication skills in English (C1); German (B2) is advantageous for Swiss authority interactions and internal collaboration

• Structured, proactive, and business-oriented mindset with a track record of delivering compliant, on-time market access while enabling innovation and operational excellence