Gra Cmc Samd & Cybersecurity Specialist

cslbehring.cl

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Global regulatory strategies for medical devices
Software as a medical device (samd) expertise
Us fda liaison for device matters
** CSL Behring is seeking a Lead, Global Regulatory Affairs Device specializing in Software as a Medical Device (SaMD) and cybersecurity to develop and implement global regulatory strategies for medical devices. The role requires extensive experience in regulatory affairs within the medical device or pharmaceutical industry, along with strong collaboration and communication skills to liaise with regulatory authorities. **

Job Summary

  • The Lead, Global Regulatory Affairs Device is responsible for developing, coordinating and implementing global Software as a Medical Device regulatory strategies for new combination and standalone medical devices.
  • This role promotes strong cross-functional collaboration and effective communication across Global Operations, Plasma Operations, R&D, Global Regulatory Affairs, and other relevant CSL business functions to drive alignment and support CSL’s strategic business objectives.
  • CSL Behring is a global biotherapeutics leader driven by our promise to save lives.

Matching Summary

Match Score: 75

** CSL Behring is seeking a Lead, Global Regulatory Affairs Device specializing in Software as a Medical Device (SaMD) and cybersecurity to develop and implement global regulatory strategies for medical devices. The role requires extensive experience in regulatory affairs within the medical device or pharmaceutical industry, along with strong collaboration and communication skills to liaise with regulatory authorities. **

Skills & Requirements

Must-have

  • global regulatory strategies for medical devices
  • Software as a Medical Device (SaMD) expertise
  • US FDA liaison for device matters
  • develop regulatory approaches
  • author and review regulatory documentation
  • ISO and IEC standards integration

Nice-to-have

  • strong cross-functional collaboration
  • innovative and flexible approaches
  • foster a culture of accountability
  • drive alignment and support business objectives

Key Requirements

  • Bachelor's degree in engineering, computer science, or scientific discipline
  • Over 5 years of progressive experience in regulatory roles
  • Extensive experience in global regulatory device environment
  • In-depth knowledge of global device regulatory requirements
  • Demonstrated ability to generate successful FDA, EU, and international submissions
  • Experienced in managing FDA and notified body interactions
  • Familiarity with emerging digital health technologies and cybersecurity requirements

Work Rights

Not specified

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