Gra Cmc Combination And Stand Alone Specialist

CSL BEHRING

Not specified (assumed hybrid based on industry norms).
Global regulatory device compliance
Us fda liaison for device matters
International health authority engagement
CSL Behring is seeking a Lead for Global Regulatory Affairs Device who will collaborate with multiple stakeholders to ensure compliance and successful market access for their medical devices and combination products. The role requires extensive experience in regulatory affairs, particularly within medical devices, as well as strong communication and leadership skills

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, initial BLAs and MAAs, international device registrations, post-approval variations/supplements, INDs, CTAs, DHFs, Q-submissions, MAFs and other relevant regulatory filings such as meeting requests and briefing packages) 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: 85

CSL Behring is seeking a Lead for Global Regulatory Affairs Device who will collaborate with multiple stakeholders to ensure compliance and successful market access for their medical devices and combination products. The role requires extensive experience in regulatory affairs, particularly within medical devices, as well as strong communication and leadership skills.

Skills & Requirements

Must-have

  • Global regulatory device compliance
  • US FDA liaison for device matters
  • International health authority engagement
  • Drug-device combination products
  • Standalone drug delivery devices
  • Plasmapheresis devices

Nice-to-have

  • Cross-functional collaboration
  • Innovative regulatory approaches
  • Strong communication skills
  • Adaptability to evolving needs

Key Requirements

  • Bachelor's degree in engineering or scientific discipline
  • Over 5 years of progressive regulatory experience
  • Extensive global regulatory device experience
  • In-depth knowledge of global device regulatory requirements
  • Demonstrated successful FDA, EU, and international submissions

Work Rights

Not specified

Tailored Resume

Cover Letter