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

CSL BEHRING

Not specified
Global regulatory strategy and execution
Medical device portfolio lifecycle management
Us fda liaison for device matters
CSL Behring is seeking a Head of Global Regulatory Affairs Device to provide strategic leadership and operational oversight for their medical device portfolio. The ideal candidate will have extensive experience in regulatory affairs within the medical device or pharmaceutical industry, with proven expertise in navigating global regulations and compliance

Job Summary

  • Provide strategic leadership and operational oversight for the Global Regulatory Affairs Device function, leading the global regulatory strategy and execution for CSL’s medical device portfolio.
  • Oversee and direct the creation of high quality, compliant regulatory documents for various device types and ensure accurate and timely change control assessments.
  • 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: 85

CSL Behring is seeking a Head of Global Regulatory Affairs Device to provide strategic leadership and operational oversight for their medical device portfolio. The ideal candidate will have extensive experience in regulatory affairs within the medical device or pharmaceutical industry, with proven expertise in navigating global regulations and compliance.

Skills & Requirements

Must-have

  • Global regulatory strategy and execution
  • Medical device portfolio lifecycle management
  • US FDA liaison for device matters
  • International health authority engagement
  • Regulatory device subject matter expert
  • Develop global device regulatory strategies

Nice-to-have

  • Foster talent and build team capabilities
  • Drive cross-functional collaboration
  • Leverage external insights for innovative approaches
  • Align regulatory strategy with business needs

Key Requirements

  • Bachelor's degree in engineering or scientific discipline
  • Over 10 years of progressive experience in regulatory roles
  • Over 5 years of managing and developing a team
  • In-depth knowledge of global device regulatory requirements
  • Proven track record in leading successful FDA, EU, and international submissions

Work Rights

Not specified

Tailored Resume

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