Wird geladen...

Head of Regulatory Affairs – Burgdorf | JobRevolt

Über den Job

Ypsomed is a leading Swiss medical technology company specializing in innovative injection systems for drug delivery, headquartered in Burgdorf with 40+ years of expertise and 2,000+ employees worldwide. As Head of Regulatory Affairs, you will shape the regulatory strategy enabling safe, compliant, and timely global market access for drug-device combination products while leading your team and serving as trusted advisor to senior leadership on all regulatory matters.

Aufgaben

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 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

Profil

University degree in Life Sciences, Biomedical/Medical Engineering, Pharmacy, or related field
10+ years of progressive Regulatory Affairs experience in medical devices in B2B sector, with substantial exposure to drug–device combination products and global markets (EU, US, Switzerland; Asia a plus)
GMP/Pharma experience 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) advantageous for Swiss authority interactions and internal collaboration
Structured, proactive, and business-oriented mindset with track record of delivering compliant, on-time market access while enabling innovation and operational excellence

Rahmenbedingungen

Position: Head of Regulatory Affairs
Pensum: 80 - 100%
Location: Burgdorf | Hybrid
Ref. No. 8131
Contact: Workforce Acquisition & Engagement Partner

Head of Regulatory Affairs

Über den Job

Über den Job

Aufgaben

Profil

Rahmenbedingungen

Skills

Weitere offene Stellen