Gra Cmc Samd & Cybersecurity Specialist

CSL Behring

**
Global software as a medical device regulatory strategies
Us fda liaison for device matters
Eu mdr 2017/745 compliance
** CSL Behring is seeking a Lead, Global Regulatory Affairs Device to develop and implement regulatory strategies for medical devices, ensuring compliance and successful market access. The ideal candidate should possess extensive regulatory experience in the medical device or biotechnology industries, particularly with Software as a Medical Device (SaMD) and related regulatory submissions. **

Job Summary

  • Develop, coordinate and implement 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: 75

** CSL Behring is seeking a Lead, Global Regulatory Affairs Device to develop and implement regulatory strategies for medical devices, ensuring compliance and successful market access. The ideal candidate should possess extensive regulatory experience in the medical device or biotechnology industries, particularly with Software as a Medical Device (SaMD) and related regulatory submissions. **

Skills & Requirements

Must-have

  • Global Software as a Medical Device regulatory strategies
  • US FDA liaison for device matters
  • EU MDR 2017/745 compliance
  • Develop global device regulatory strategies
  • Cybersecurity requirements for SaMD/SiMD

Nice-to-have

  • Strong cross-functional collaboration
  • Leverage external insights
  • 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
  • Demonstrated ability to generate successful FDA, EU, and international submissions

Work Rights

Not specified

Tailored Resume

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