Not specified (assumed hybrid based on industry norms)
Global regulatory strategy
Medical device portfolio management
Us fda liaison
CSL Behring is seeking a Head of Global Regulatory Affairs Device to lead their regulatory strategy for medical devices, ensuring compliance and successful market access. The ideal candidate should possess extensive experience in regulatory roles within the medical device industry and demonstrate strong leadership skills to mentor a high-performing team
Job Summary
The Head of Global Regulatory Affairs Device is responsible for providing strategic leadership and operational oversight for the Global Regulatory Affairs Device function, leading the global regulatory strategy and execution for CLS’s medical device portfolio.
This role involves close collaboration with internal stakeholders on regulatory strategy issues, serving as the primary liaison to the US FDA for device matters, and working with regional regulatory staff to engage with international health authorities.
Key responsibilities include defining and optimizing regulatory strategies, mentoring and developing a high-performing regulatory affairs team, and overseeing the creation of high-quality, compliant regulatory documents.
Matching Summary
Match Score: 85
CSL Behring is seeking a Head of Global Regulatory Affairs Device to lead their regulatory strategy for medical devices, ensuring compliance and successful market access. The ideal candidate should possess extensive experience in regulatory roles within the medical device industry and demonstrate strong leadership skills to mentor a high-performing team.
Skills & Requirements
Must-have
Global Regulatory Strategy
Medical Device Portfolio Management
US FDA Liaison
International Health Authorities Engagement
Regulatory Compliance
Drug Device Combination Products
Nice-to-have
Cross-functional Collaboration
Talent Development
Continuous Learning Culture
Innovative Regulatory Approaches
Operational Excellence
Key Requirements
Bachelor's degree in engineering or scientific discipline
Over 10 years of progressive regulatory experience