CSL Behring is seeking a Lead in Global Regulatory Affairs Device, responsible for collaborating with multiple departments to ensure compliance and successful market access for medical devices and drug-device combination products. The ideal candidate will have extensive regulatory experience, particularly with global device regulations, and will play a key role in strategic decision-making and communication with regulatory authorities
Job Summary
The Lead, Global Regulatory Affairs Device is responsible for partnering with various stakeholders to address regulatory strategy challenges.
This role promotes strong collaboration and effective communication across Global Operations, R&D, and Regulatory Affairs.
CSL Behring is committed to innovation and saving lives through their biotherapeutics.
Matching Summary
Match Score: 85
CSL Behring is seeking a Lead in Global Regulatory Affairs Device, responsible for collaborating with multiple departments to ensure compliance and successful market access for medical devices and drug-device combination products. The ideal candidate will have extensive regulatory experience, particularly with global device regulations, and will play a key role in strategic decision-making and communication with regulatory authorities.
Skills & Requirements
Must-have
Regulatory strategy expertise
Experience with FDA submissions
Global device regulatory compliance
Nice-to-have
Strong cross-functional collaboration
Exceptional communication skills
Leadership in regulatory teams
Key Requirements
Bachelor’s degree in engineering or science
Over 5 years of regulatory experience
In-depth knowledge of global device regulatory requirements