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Responsibilities:
- Represent the regulatory function on cross-functional teams and interact with authorities.
- Build and execute bold regulatory strategies for FDA Pharma and IVDR programs.
- Coordinate regulatory submissions including EU IVDR Technical Documentation and 510(k) premarket notifications.
Qualifications:
- Bachelor's degree in life science or equivalent advanced degree preferred.
- Minimum 8+ years of direct regulatory experience in medical devices or pharma.
- Direct experience with FDA Pharma and IVDR submissions highly preferred.
Skills:
- Working knowledge of US and EU medical device/IVD/IVDR and FDA Pharma requirements.
- Proactive, self-directed, and skilled in managing multiple projects.
- Excellent communication and negotiation skills with regulators.
Natera
Natera is a clinical genetic testing company specializing in non-invasive cell-free DNA and liquid biopsy testing. The team consists of highly dedicated professionals from world-class institutions who care deeply for their work and each other.