Gra Cmc Combination And Stand Alone Specialist

cslbehring.cz

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Global regulatory device compliance
Drug device combination products
Plasmapheresis devices
** CSL Behring is seeking a Lead, Global Regulatory Affairs Device Specialist to oversee regulatory strategies for medical devices, ensuring worldwide compliance and market access. The ideal candidate will have extensive experience in regulatory affairs within the medical device or pharmaceutical industry, working closely with cross-functional teams and regulatory bodies. **

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.
  • Ensure worldwide regulatory device compliance and successful market access across all regions by closely collaborating with internal stakeholders and serving as the primary liaison to the US FDA for device matters.
  • Author and review high-quality, compliant regulatory documents based on relevant US, EU, and ISO standards for the device portfolio within defined timelines as per R&D and commercial objectives.

Matching Summary

Match Score: 75

** CSL Behring is seeking a Lead, Global Regulatory Affairs Device Specialist to oversee regulatory strategies for medical devices, ensuring worldwide compliance and market access. The ideal candidate will have extensive experience in regulatory affairs within the medical device or pharmaceutical industry, working closely with cross-functional teams and regulatory bodies. **

Skills & Requirements

Must-have

  • global regulatory device compliance
  • drug device combination products
  • plasmapheresis devices
  • regulatory strategy challenges
  • market access across all regions
  • US FDA liaison for device matters

Nice-to-have

  • cross-functional collaboration
  • innovative regulatory approaches
  • operational excellence
  • strong positive relationships with regulators

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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