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 lead the regulatory strategy for their medical device portfolio, focusing on compliance and market access across various regions. The ideal candidate will possess extensive experience in regulatory roles within the medical device industry, along with strong leadership and communication skills

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.
  • Key responsibilities include overseeing and directing the creation of high quality, compliant regulatory documents and serving as the regulatory device subject matter expert for patient-integrated care solutions initiatives.

Matching Summary

Match Score: 85

CSL Behring is seeking a Head of Global Regulatory Affairs Device to lead the regulatory strategy for their medical device portfolio, focusing on compliance and market access across various regions. The ideal candidate will possess extensive experience in regulatory roles within the medical device industry, along with strong leadership and communication skills.

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
  • Device regulatory assessments for due diligence

Nice-to-have

  • Foster talent and continuous learning
  • Drive alignment with business objectives
  • Innovative regulatory approaches
  • Operational excellence in regulatory compliance

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
  • Extensive experience in global regulatory device environment
  • 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

Cover Letter