Senior Regulatory Affairs Manager
Alira Health(4 days ago)
About this role
The Senior Regulatory Affairs Manager at Alira Health plays a vital role in guiding, managing, and streamlining regulatory projects focused on EU and FDA markets. The position involves collaboration with clients and internal teams to ensure compliance and successful product registration strategies across medical devices and combination products.
Required Skills
- Regulatory Affairs
- FDA
- MDR
- IVDR
- Medical Devices
- Regulatory Submissions
- EU Regulations
- Project Management
- Technical Documentation
- Client Liaison
Qualifications
- BS in a scientific discipline
- 7+ years in medical device regulatory role
- Knowledge of FDA procedures
- Knowledge of MDR and IVDR
About Alira Health
alirahealth.comWe're a patient-centric and technology-enabled advisory firm and CRO that supports healthcare and life sciences organizations across the solutions lifecycle.
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