Gra Cmc Combination And Stand Alone Specialist

kennenlerntage-cslbehring.de

Not specified (assumed to be hybrid or onsite based on industry standards).
Global regulatory device compliance
Us fda liaison
International health authorities engagement
The job posting seeks a Lead, Global Regulatory Affairs Device at CSL Behring, focused on ensuring regulatory compliance and market access for various medical devices and drug-device combination products. The role emphasizes collaboration with cross-functional teams, particularly with R&D and Quality, to navigate complex regulatory landscapes and foster innovation

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 for plasmapheresis devices, drug device combination products, standalone drug delivery devices, and ancillary devices.
  • Directly liaise and negotiate with the US FDA and oversee and advise regional regulatory staff on discussions with international health authorities and agencies for device-related matters during development and commercial use.
  • 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

The job posting seeks a Lead, Global Regulatory Affairs Device at CSL Behring, focused on ensuring regulatory compliance and market access for various medical devices and drug-device combination products. The role emphasizes collaboration with cross-functional teams, particularly with R&D and Quality, to navigate complex regulatory landscapes and foster innovation.

Skills & Requirements

Must-have

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

Nice-to-have

  • strong cross-functional collaboration
  • effective communication
  • innovative regulatory approaches
  • operational excellence
  • culture of curiosity and empathy

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

Cover Letter