Shape global approval/registration strategies for medical devices in the anesthesia, intensive care and warming therapy product areas
Lead a 13-member Regulatory Affairs team, combining leadership, advisory and hands-on implementation
Accelerate market access while ensuring compliance and maintaining current approvals — nationally and internationally
Develop and take responsibility for parts of global approval and re-registration strategies and manage implementation through to final documentation
Provide technical and disciplinary leadership for the Regulatory Affairs team
Further develop structures, processes and methods
Provide proactive regulatory advice as one of the regulatory points of contact
Actively support regulatory authority exchanges (national/international)
Continuously expand knowledge of regulatory requirements and modern methods
Operational contribution: take on partial tasks/products to help achieve goals and relieve the team

Degree in engineering, natural sciences or a comparable qualification
Many years of professional experience and ideally initial leadership experience in an internationally oriented Regulatory Affairs role
Solid, up-to-date know-how of international approval/regulatory requirements, product liability and relevant standards/regulations in medical technology (e.g., ISO 13485, ISO 14971, 21 CFR Part 820, MDR)
Very good knowledge of regulatory software and databases and business-fluent English
Confident communication skills, strong stakeholder management and clear goal/result orientation

Team Leader Regulatory Affairs – m/f/d

Key skills