Regulatory Affairs Advisor; Fully Remote

• 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 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.