Gra Cmc Samd & Cybersecurity Specialist

cslbehring.ch

Not specified
Global regulatory strategies
Software as a medical device
Us fda liaison
CSL Behring is seeking a Lead Global Regulatory Affairs Device specialist to develop and implement regulatory strategies for medical devices, ensuring compliance and market access worldwide. The role requires extensive experience in regulatory affairs, collaboration with cross-functional teams, and expertise in navigating both US and international regulatory environments

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, ensuring worldwide regulatory device compliance and successful market access across all regions.
  • 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 including plasmapheresis devices, blood establishment computer software (BECS), drug-device combination products, ancillary devices, SaMD/SiMD, mobile applications, and connected platforms.
  • CSL Behring is a global biotherapeutics leader driven by our promise to save lives, focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.

Matching Summary

Match Score: 85

CSL Behring is seeking a Lead Global Regulatory Affairs Device specialist to develop and implement regulatory strategies for medical devices, ensuring compliance and market access worldwide. The role requires extensive experience in regulatory affairs, collaboration with cross-functional teams, and expertise in navigating both US and international regulatory environments.

Skills & Requirements

Must-have

  • global regulatory strategies
  • Software as a Medical Device
  • US FDA liaison
  • international health authorities
  • regulatory documentation authoring
  • ISO and IEC standards integration
  • SaMD/SiMD cybersecurity requirements

Nice-to-have

  • patient-integrated care solutions
  • due diligence activities
  • evolving global regulatory intelligence
  • operational excellence
  • diverse cross-functional stakeholders

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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