Gra Cmc Samd & Cybersecurity Specialist

CSL Behring

**
Regulatory compliance expertise
Experience with samd/simd
Strong cross-functional collaboration
** CSL Behring is seeking a Lead, Global Regulatory Affairs Device to develop and implement regulatory strategies for medical devices, ensuring compliance and facilitating market access globally. The ideal candidate will have extensive experience in regulatory affairs, particularly within the medical device sector, and demonstrate strong leadership and communication skills. **

Job Summary

  • CSL Behring is a global biotherapeutics leader focused on saving lives.
  • The role involves developing global regulatory strategies for medical devices.
  • Collaboration across various functions is essential to support strategic business objectives.

Matching Summary

Match Score: 75

** CSL Behring is seeking a Lead, Global Regulatory Affairs Device to develop and implement regulatory strategies for medical devices, ensuring compliance and facilitating market access globally. The ideal candidate will have extensive experience in regulatory affairs, particularly within the medical device sector, and demonstrate strong leadership and communication skills. **

Skills & Requirements

Must-have

  • Regulatory compliance expertise
  • Experience with SaMD/SiMD
  • Strong cross-functional collaboration

Nice-to-have

  • Leadership in regulatory teams
  • Knowledge of digital health technologies
  • Ability to manage ambiguity

Key Requirements

  • Bachelor's degree in engineering or related field
  • Over 5 years of regulatory experience
  • Proven expertise in global device regulatory requirements

Work Rights

Not specified

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