Gra Cmc Combination And Stand Alone Specialist

csl.co.th

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Global regulatory device compliance
Us fda liaison for device matters
Drug device combination products
** CSL Behring is seeking a Lead, Global Regulatory Affairs Device to oversee regulatory strategy and compliance for various medical devices and drug-device combination products. The role requires extensive experience in regulatory affairs, particularly with FDA and international health authorities, and emphasizes collaboration across multiple departments to ensure successful market access and compliance. **

Job Summary

  • Partner 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.
  • Author and review high-quality, compliant regulatory documents (e.g., 510(k), De Novo, PMAs, technical documentation for CE mark application) based on relevant US, EU, and ISO standards for the device portfolio within defined timelines.

Matching Summary

Match Score: 75

** CSL Behring is seeking a Lead, Global Regulatory Affairs Device to oversee regulatory strategy and compliance for various medical devices and drug-device combination products. The role requires extensive experience in regulatory affairs, particularly with FDA and international health authorities, and emphasizes collaboration across multiple departments to ensure successful market access and compliance. **

Skills & Requirements

Must-have

  • Global regulatory device compliance
  • US FDA liaison for device matters
  • Drug device combination products
  • Standalone drug delivery devices
  • Plasmapheresis devices
  • Author and review regulatory documents

Nice-to-have

  • Innovative regulatory approaches
  • Cross-functional collaboration
  • Strong relationship management
  • Adaptability to evolving business needs

Key Requirements

  • Bachelor's degree in engineering or science
  • Over 5 years of progressive regulatory experience
  • Extensive global regulatory device experience
  • 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

Cover Letter