Gra Cmc Samd & Cybersecurity Specialist

CSL SEQIRUS

Not specified
Software as a medical device regulatory strategies
Global device regulatory compliance
Us fda liaison
CSL Seqirus is seeking a Lead, Global Regulatory Affairs Device to develop and execute global regulatory strategies for medical devices, including Software as a Medical Device (SaMD). The role requires extensive regulatory experience and strong collaboration across various functions, primarily focusing on compliance and market access

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.
  • Collaborate with cross-functional partners across Global Regulatory Affair, R&D, Quality, Global Operations, Plasma Operations, IT, and other business functions to execute regulatory strategies for a broad portfolio.
  • CSL Behring is a global biotherapeutics leader driven by our promise to save lives, focused on serving patients’ needs by using the latest technologies.

Matching Summary

Match Score: 85

CSL Seqirus is seeking a Lead, Global Regulatory Affairs Device to develop and execute global regulatory strategies for medical devices, including Software as a Medical Device (SaMD). The role requires extensive regulatory experience and strong collaboration across various functions, primarily focusing on compliance and market access.

Skills & Requirements

Must-have

  • Software as a Medical Device regulatory strategies
  • global device regulatory compliance
  • US FDA liaison
  • international health authority engagement
  • regulatory submission authoring and review
  • ISO and IEC standards integration
  • cybersecurity requirements for SaMD/SiMD

Nice-to-have

  • strong cross-functional collaboration
  • effective communication
  • driving alignment
  • fostering a culture of accountability
  • leveraging external insights
  • innovative and flexible approaches

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

Work Rights

Not specified

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