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

labsites.cshl.edu

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Global regulatory strategy
Medical device lifecycle management
Us fda liaison
** The Head of Global Regulatory Affairs Device at CSL Behring is responsible for leading global regulatory strategies and ensuring compliance for the company’s medical device portfolio. The role requires extensive experience in regulatory affairs within the medical device industry, as well as strong leadership skills to manage and develop a high-performing team. **

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, serving as the primary liaison to the US FDA for device matters, and closely 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

** The Head of Global Regulatory Affairs Device at CSL Behring is responsible for leading global regulatory strategies and ensuring compliance for the company’s medical device portfolio. The role requires extensive experience in regulatory affairs within the medical device industry, as well as strong leadership skills to manage and develop a high-performing team. **

Skills & Requirements

Must-have

  • Global Regulatory Strategy
  • Medical Device Lifecycle Management
  • US FDA Liaison
  • International Health Authority Engagement
  • Drug Device Combination Products
  • Software as a Medical Device (SaMD)

Nice-to-have

  • Cross-functional Collaboration
  • Talent Development
  • Continuous Learning Culture
  • Strategic Business Objectives Alignment
  • Innovative Regulatory Approaches

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
  • Experienced in managing FDA and notified body interactions

Work Rights

Not specified

Tailored Resume

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