Gra Cmc Medical Device Lead (m/f/x)

CSL Limited

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Global regulatory strategy and execution
Us fda liaison for device matters
Medical device portfolio lifecycle management
** CSL Limited is seeking a Head of Global Regulatory Affairs Device to provide strategic leadership and operational oversight for its medical device portfolio. The role involves managing regulatory strategies, ensuring compliance, and fostering a high-performance team while collaborating with various stakeholders. **

Job Summary

  • The Head of Global Regulatory Affairs Device is responsible for providing strategic leadership and operational oversight for the Global Regulatory Affairs Device function.
  • This role promotes strong cross-functional collaboration and effective communication across Global Operations, R&D, Global Regulatory Affairs, and other relevant CSL business functions to drive alignment and support CSL’s strategic business objectives.
  • CSL Behring is a global biotherapeutics leader driven by our promise to save lives, focused on serving patients’ needs by using the latest technologies.

Matching Summary

Match Score: 75

** CSL Limited is seeking a Head of Global Regulatory Affairs Device to provide strategic leadership and operational oversight for its medical device portfolio. The role involves managing regulatory strategies, ensuring compliance, and fostering a high-performance team while collaborating with various stakeholders. **

Skills & Requirements

Must-have

  • Global regulatory strategy and execution
  • US FDA liaison for device matters
  • Medical device portfolio lifecycle management
  • Cross-functional collaboration
  • Regulatory device subject matter expert

Nice-to-have

  • Foster talent and build team capabilities
  • Innovative regulatory approaches
  • Strong relationships with regulators
  • Adaptability to evolving business needs

Key Requirements

  • Bachelor's degree in engineering or scientific discipline
  • Over 10 years of progressive regulatory experience
  • Over 5 years of managing regulatory professionals
  • In-depth knowledge of global device regulatory requirements
  • Proven track record in leading successful submissions

Work Rights

Not specified

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