Gra Cmc Combination And Stand Alone Specialist

Cslbehring Com Au

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Global regulatory device compliance
Drug device combination products
Standalone drug delivery devices
** CSL Behring is seeking a Lead, Global Regulatory Affairs Device specialist to manage regulatory strategies and compliance for a portfolio of medical devices and drug-device combinations. The role requires extensive experience in global regulatory environments, particularly in the medical device sector, and strong collaboration across various departments to ensure successful market access and compliance. **

Job Summary

  • The Lead, Global Regulatory Affairs Device is responsible for partnering closely with R&D, Manufacturing, Operations, Quality, and Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions that meet evolving device regulatory and compliance requirements.
  • This role promotes strong cross-functional collaboration and effective communication across Global Operations, R&D, Global Regulatory Affairs, and other relevant CSL business functions to drive alignment and support CSL’s strategic business objectives.
  • At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out.

Matching Summary

Match Score: 75

** CSL Behring is seeking a Lead, Global Regulatory Affairs Device specialist to manage regulatory strategies and compliance for a portfolio of medical devices and drug-device combinations. The role requires extensive experience in global regulatory environments, particularly in the medical device sector, and strong collaboration across various departments to ensure successful market access and compliance. **

Skills & Requirements

Must-have

  • global regulatory device compliance
  • drug device combination products
  • standalone drug delivery devices
  • US FDA liaison
  • international health authorities engagement
  • regulatory strategy development
  • device regulatory assessments

Nice-to-have

  • cross-functional collaboration
  • effective communication
  • operational excellence
  • innovative regulatory approaches
  • culture of curiosity and empathy

Key Requirements

  • Bachelor's degree in engineering 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
  • Demonstrated leadership in managing and developing teams

Work Rights

Not specified

Tailored Resume

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