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

csl.co.th

Not specified (potentially hybrid or onsite based on typical industry standards).
Global regulatory strategy and execution
Medical device portfolio lifecycle management
Us fda liaison for device matters
The Head of Global Regulatory Affairs Device at CSL Behring is responsible for providing strategic leadership and oversight of regulatory affairs for the company's medical device portfolio. The role demands extensive experience in regulatory compliance, effective team management, and proactive collaboration with cross-functional teams to drive successful market access and compliance across global markets

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 working with regional regulatory staff to engage with international health authorities.
  • The position demands proactive leadership and strategic direction to the Global Regulatory Affairs Device function, including mentoring, developing, and coaching a high-performing regulatory affairs team.

Matching Summary

Match Score: 85

The Head of Global Regulatory Affairs Device at CSL Behring is responsible for providing strategic leadership and oversight of regulatory affairs for the company's medical device portfolio. The role demands extensive experience in regulatory compliance, effective team management, and proactive collaboration with cross-functional teams to drive successful market access and compliance across global markets.

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
  • Global regulatory device strategies

Nice-to-have

  • Foster talent and build team capabilities
  • Drive alignment with strategic business objectives
  • Leverage external insights for innovative approaches
  • Culture of continuous learning and professional growth
  • Motivating, mentoring, and guiding diverse teams

Key Requirements

  • Over 10 years of progressive experience in regulatory roles
  • Over 5 years of managing and developing a team
  • Bachelor's degree in engineering or scientific discipline
  • Advanced degree (MS, PhD) strongly preferred
  • Extensive experience in global regulatory device environment
  • Proven track record in leading successful FDA, EU, and international submissions

Work Rights

Not specified

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