Related skills
project management regulatory affairs iso 13485 mdsap fda📋 Description
- Oversee regulatory compliance for novel medical devices (FDA, ISO).
- Manage regulatory submissions pipeline for all OXOS products.
- Monitor national and global regulatory developments.
- Ensure submissions are accurate, compliant, and timely.
- Collaborate with teams to inform strategy with Regulatory Affairs.
- Plan regulatory strategies with Regulatory Affairs and PMO.
🎯 Requirements
- Bachelor's degree or higher in a relevant field.
- Regulatory experience in FDA-regulated medical devices.
- Knowledge of MDSAP, ISO 13485, ISO 14971, IEC 60601.
- Attention to detail.
- Clear, precise written and verbal communication.
- Project management skills.
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