Head of Regulatory Affairs

Ypsomed is a leading Swiss medical technology company specializing in innovative injection systems for drug delivery. Headquartered in Burgdorf, Switzerland, the company serves pharma partners and patients worldwide, focusing on improving patient outcomes through user-centric design, regulatory excellence, and sustainable manufacturing practices. As Head of Regulatory Affairs, you will shape the regulatory strategy to enable safe, compliant, and timely global market access for drug-device combination products and medical devices, ensuring innovation and compliance go hand in hand.

• 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, including 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, including activity planning, goal setting, performance management, capability building, and acting 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 SOPs.
• Drive continuous improvement of regulatory processes, templates, and tools (including digital/automation opportunities) to increase speed, consistency, and audit readiness across the product portfolio.