Gra Cmc Combination And Stand Alone Specialist

Centerforintegrationscience

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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 oversee regulatory strategy and compliance for various medical devices, including plasmapheresis and drug-device combination products. The ideal candidate will have extensive regulatory experience in the medical device or pharmaceutical industry and strong collaboration skills to work across multiple functions. **

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.
  • Ensure worldwide regulatory device compliance and successful market access across all regions, closely collaborating with internal stakeholders on regulatory strategy issues and serving as primary liaison to the US FDA for device matters.
  • 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.

Matching Summary

Match Score: 75

** CSL Behring is seeking a Lead, Global Regulatory Affairs Device specialist to oversee regulatory strategy and compliance for various medical devices, including plasmapheresis and drug-device combination products. The ideal candidate will have extensive regulatory experience in the medical device or pharmaceutical industry and strong collaboration skills to work across multiple functions. **

Skills & Requirements

Must-have

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

Nice-to-have

  • driving alignment and support
  • fostering a culture of accountability
  • leveraging external insights
  • operational excellence

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

Work Rights

Not specified

Tailored Resume

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