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

Csmmh

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Global regulatory strategy and execution
Medical device portfolio lifecycle management
Us fda liaison
** The Head of Global Regulatory Affairs Device at CSL Behring is a strategic leadership role responsible for overseeing regulatory compliance and market access for the company's medical device portfolio. The position requires extensive experience in regulatory affairs, team leadership, and collaboration with cross-functional teams to ensure successful product development and commercialization. **

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, leading the global regulatory strategy and execution for CLS’s medical device portfolio.
  • This role requires close collaboration with internal stakeholders on regulatory strategy issues, developing approaches to address regulatory and compliance matters, and serving as the primary liaison to the US FDA for device matters.
  • The position 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.

Matching Summary

Match Score: 75

** The Head of Global Regulatory Affairs Device at CSL Behring is a strategic leadership role responsible for overseeing regulatory compliance and market access for the company's medical device portfolio. The position requires extensive experience in regulatory affairs, team leadership, and collaboration with cross-functional teams to ensure successful product development and commercialization. **

Skills & Requirements

Must-have

  • Global regulatory strategy and execution
  • Medical device portfolio lifecycle management
  • US FDA liaison
  • International health authority engagement
  • Regulatory compliance and market access
  • Cross-functional collaboration

Nice-to-have

  • Talent development and team building
  • Innovative regulatory approaches
  • Patient-integrated care solutions expertise
  • Digital health technologies familiarity
  • Cybersecurity requirements advisory

Key Requirements

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

Work Rights

Not specified

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