Head of Regulatory Affairs

仕事内容

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. As Head of Regulatory Affairs at Ypsomed, you will shape the regulatory strategy that enables safe, compliant, and timely global market access for our drug-device combination products and medical devices. You will lead and develop our Regulatory Affairs team, partner closely with R&D, Quality, and Commercial, and serve as a trusted advisor to senior leadership on all regulatory matters. In this role, you ensure that innovation and compliance go hand in hand-accelerating patient access while maintaining the highest standards of quality and regulatory excellence. Head of Regulatory Affairs | 80 - 100% Ref. No. 8131 Location: Burgdorf | Hybrid 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 Ypsomed - making the treatment of chronic diseases possible Ypsomed is the leading developer and manufacturer of injection systems for the self-administration of liquid medication. As the reliable partner of pharmaceutical and biotech companies for more than 40 years, Ypsomed provides tailored selfcare solutions to meet specific needs. Backed by a proven track record, Ypsomed offers the most comprehensive and innovative platform portfolio for pens, autoinjectors, and on-body devices. Delivered with best-in-class execution and ready to integrate with digital health services, these solutions help simplify therapy and improve the quality of life for millions of people living with chronic conditions. Ypsomed is headquartered in Burgdorf, Switzerland, and operates a global network of manufacturing facilities. More than 2,000 employees worldwide are committed every day to making selfcare simpler and easier. Contact Workforce Acquisition & Engagement Partner Your future place of work Burgdorf 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 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. As Head of Regulatory Affairs at Ypsomed, you will shape the regulatory strategy that enables safe, compliant, and timely global market access for our drug-device combination products and medical devices. You will lead and develop our Regulatory Affairs team, partner closely with R&D, Quality, and Commercial, and serve as a trusted advisor to senior leadership on all regulatory matters. In this role, you ensure that innovation and compliance go hand in hand-accelerating patient access while maintaining the highest standards of quality and regulatory excellence. Head of Regulatory Affairs | 80 - 100% Ref. No. 8131 Location: Burgdorf | Hybrid 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 Ypsomed - making the treatment of chronic diseases possible Ypsomed is the leading developer and manufacturer of injection systems for the self-administration of liquid medication. As the reliable partner of pharmaceutical and biotech companies for more than 40 years, Ypsomed provides tailored selfcare solutions to meet specific needs. Backed by a proven track record, Ypsomed offers the most comprehensive and innovative platform portfolio for pens, autoinjectors, and on-body devices. Delivered with best-in-class execution and ready to integrate with digital health services, these solutions help simplify therapy and improve the quality of life for millions of people living with chronic conditions. Ypsomed is headquartered in Burgdorf, Switzerland, and operates a global network of manufacturing facilities. More than 2,000 employees worldwide are committed every day to making selfcare simpler and easier. Contact Workforce Acquisition & Engagement Partner Your future place of work Burgdorf jida473504cs jit0937cs jiy26cs

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