Global Regulatory Affairs Device Lead (Associate Director)
Sanofi(4 months ago)
About this role
The Global Regulatory Affairs Device Lead (Associate Director) at Sanofi will establish and drive global regulatory strategies for medical devices, combination products, digital health and IVDs across the product lifecycle. The role partners with R&D, Device, Manufacturing, Quality and regulatory authorities to enable product approvals and lifecycle management. It is a visible position within Global R&D’s GRA CMC & GRA Device organization supporting global submission planning and regulatory compliance.
Required Skills
- Regulatory Strategy
- Device Submissions
- Risk Assessment
- Health Authorities
- Design Controls
- Lifecycle Management
- Cross-Functional Collaboration
- Project Leadership
- Clinical Development
- Regulatory Documentation
+2 more
Qualifications
- Bachelor's Degree in Scientific or Engineering Discipline
- Graduate Degree Preferred
About Sanofi
sanofi.comSanofi is a research & development-driven, AI-powered healthcare biopharma company committed to improving lives through innovative medicines & vaccines.
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