Senior Manager, US Licensure

Job Summary

Seeking a remote, full-time Senior Manager, US Licensure and UDI, who will provide global commercial quality oversight and lead end-to-end process improvements for UDI management and USA licensure, ensuring regulatory compliance and operational excellence through cross-functional collaboration.

Key responsibilities

• Provide quality oversight for UDI processes and lifecycle management of UDI data
• Lead the continuous improvement of global UDI processes to enhance compliance and operational excellence
• Act as the US Licensure subject matter expert, managing data for licensure applications and maintaining documentation

Required qualifications

• Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or related field; advanced degree preferred
• 8-10 years of experience in Quality, Regulatory Affairs, or Compliance within a medical device or regulated healthcare environment
• Strong knowledge of global medical device regulations and standards (e.g., FDA, EU MDR, ISO 13485)
• Experience with Process Excellence methodologies (Lean, Six Sigma) across diverse business areas
• Proven ability to execute work in a highly matrixed, cross-functional environment