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

CSL Vifor

**
Global regulatory strategy and execution
Medical device portfolio lifecycle management
Us fda liaison for device matters
** CSL Vifor is seeking a Head of Global Regulatory Affairs Device to lead their regulatory strategy and compliance efforts for their medical device portfolio. The ideal candidate will possess extensive experience in regulatory roles within the medical device or pharmaceutical industries and will be responsible for ensuring successful market access and compliance across global regions. **

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, serving as the primary liaison to the US FDA for device matters, and working with regional regulatory staff to engage with international health authorities.
  • CSL Behring is a global biotherapeutics leader driven by its promise to save lives, focused on serving patients' needs by using the latest technologies to discover, develop and deliver innovative therapies.

Matching Summary

Match Score: 75

** CSL Vifor is seeking a Head of Global Regulatory Affairs Device to lead their regulatory strategy and compliance efforts for their medical device portfolio. The ideal candidate will possess extensive experience in regulatory roles within the medical device or pharmaceutical industries and will be responsible for ensuring successful market access and compliance across global regions. **

Skills & Requirements

Must-have

  • Global regulatory strategy and execution
  • Medical device portfolio lifecycle management
  • US FDA liaison for device matters
  • Cross-functional collaboration
  • Regulatory compliance and market access
  • Develop and implement regulatory policies

Nice-to-have

  • Talent development and team building
  • Continuous learning and professional growth
  • Innovative regulatory approaches
  • Operational excellence
  • Inclusion and Belonging

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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