Gra Cmc Combination And Stand Alone Specialist

CSL Behring

Not specified
Global regulatory device compliance
Drug device combination products
Standalone drug delivery devices
CSL Behring is seeking a Lead, Global Regulatory Affairs Device specialist to develop and implement regulatory strategies for its medical device portfolio. The role involves collaboration across various departments to ensure compliance with global regulatory requirements, particularly for plasmapheresis and drug-device combination products

Job Summary

  • 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 for plasmapheresis devices, drug device combination products, standalone drug delivery devices, and ancillary devices.
  • 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.
  • You Belong at CSL: 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: 85

CSL Behring is seeking a Lead, Global Regulatory Affairs Device specialist to develop and implement regulatory strategies for its medical device portfolio. The role involves collaboration across various departments to ensure compliance with global regulatory requirements, particularly for plasmapheresis and drug-device combination products.

Skills & Requirements

Must-have

  • global regulatory device compliance
  • drug device combination products
  • standalone drug delivery devices
  • US FDA liaison
  • EU MDR
  • ISO 13485
  • ISO 14971

Nice-to-have

  • innovative regulatory approaches
  • cross-functional collaboration
  • driving alignment
  • operational excellence
  • fostering a culture of accountability

Key Requirements

  • Bachelor's degree in engineering or science
  • Over 5 years of progressive regulatory experience
  • Extensive global regulatory device experience
  • Proven expertise in global pharmaceutical and biotechnological drug development
  • 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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