Senior Regulatory Affairs Specialist (m/f/d) Roche Penzberg

Bertrandt ist ein international tätiger Engineering‑Dienstleister, der innovative technische Lösungen für anspruchsvolle Industrieprojekte entwickelt. An über 50 Standorten weltweit arbeiten rund 12.000 Mitarbeitende eng mit Kunden aus technologiegetriebenen Branchen zusammen. Bei Bertrandt agieren Sie in einem professionellen, partnerschaftlichen Umfeld und leisten einen wichtigen Beitrag zur erfolgreichen Umsetzung komplexer Projekte.

What to Expect :

• Preparation, compilation and maintenance of regulatory documentation as well as marketing authorization and registration dossiers for complex products in an international context
• Development and implementation of regulatory strategies in accordance with global requirements
• Identification and management of regulatory risks
• Providing advice on regulatory issues and ensuring adherence to international compliance and approval requirements
• Supporting audits, including preparing for, conducting, and following up on corrective actions
• Providing technical support and mentoring to team members 
• Actively contributing to process optimization, digitalization initiatives and the further development of regulatory systems, tools and data management
• Analyzing complex issues and developing and implementing sustainable and innovative solutions

What you bring:

• A completed bachelor’s or master’s degree in life sciences, data science, or a related field; alternatively, a completed apprenticeship as a technician, laboratory technician, or a comparable qualification
• Professional experience in Regulatory Affairs, Research & Development or Quality Management
• Initial experience in the field of Healthcare Regulatory Affairs
• Experience in developing and implementing improvement and change processes
• Business-level proficiency in spoken and written English
• Experience from Regulatory Affairs in China would be very desirable

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