Title:  Head of Regulatory Affairs

Your main tasks

• 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

Your profile

• 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