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

CSL SEQIRUS

Not specified
Global regulatory strategy and execution
Medical device portfolio lifecycle management
Us fda liaison for device matters
CSL Seqirus is seeking a Head of Global Regulatory Affairs Device to provide strategic leadership and oversight for their medical device portfolio. The ideal candidate will have extensive experience in regulatory affairs within the medical device or pharmaceutical industries, with a strong focus on compliance and market access

Job Summary

  • Provide strategic leadership and operational oversight for the Global Regulatory Affairs Device function, leading global regulatory strategy and execution for CSL’s medical device portfolio.
  • Directly liaise and negotiate with the US FDA and oversee regional regulatory staff in discussions with international health authorities for device-related matters.
  • Ensure accurate and timely change control assessments and advise on regulatory device strategies, solutions to engineering problems, and interpretation of results.

Matching Summary

Match Score: 85

CSL Seqirus is seeking a Head of Global Regulatory Affairs Device to provide strategic leadership and oversight for their medical device portfolio. The ideal candidate will have extensive experience in regulatory affairs within the medical device or pharmaceutical industries, with a strong focus on compliance and market access.

Skills & Requirements

Must-have

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

Nice-to-have

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

Key Requirements

  • Bachelor's degree in engineering or scientific discipline
  • Over 10 years of progressive regulatory experience
  • Over 5 years of managing regulatory professionals
  • Extensive global regulatory device environment experience
  • Proven track record in leading successful FDA/EU submissions

Work Rights

Not specified

Tailored Resume

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