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CSL Behring is seeking a Lead, Global Regulatory Affairs Device to develop and implement regulatory strategies for medical devices, ensuring compliance and facilitating market access globally. The ideal candidate will have extensive experience in regulatory affairs, particularly within the medical device sector, and demonstrate strong leadership and communication skills.
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Job Summary
CSL Behring is a global biotherapeutics leader focused on saving lives.
The role involves developing global regulatory strategies for medical devices.
Collaboration across various functions is essential to support strategic business objectives.
Matching Summary
Match Score: 75
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CSL Behring is seeking a Lead, Global Regulatory Affairs Device to develop and implement regulatory strategies for medical devices, ensuring compliance and facilitating market access globally. The ideal candidate will have extensive experience in regulatory affairs, particularly within the medical device sector, and demonstrate strong leadership and communication skills.
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Skills & Requirements
Must-have
Regulatory compliance expertise
Experience with SaMD/SiMD
Strong cross-functional collaboration
Nice-to-have
Leadership in regulatory teams
Knowledge of digital health technologies
Ability to manage ambiguity
Key Requirements
Bachelor's degree in engineering or related field
Over 5 years of regulatory experience
Proven expertise in global device regulatory requirements