Regulatory Affairs Advisor (Fully Remote)

Natera; United States; À distance; USD 120 000 - 180 000; Plein temps

Résumé du poste

Natera is seeking a senior Regulatory Affairs professional to lead the regulatory function on cross-functional teams and interact with authorities on FDA Pharma and EU IVDR programs.

You will build and execute bold regulatory strategies and coordinate submissions, including EU IVDR Technical Documentation and 510(k) premarket notifications, to enable timely product approvals and market access.

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.

Responsabilités

• 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.

Connaissances

Regulatory strategy

FDA/IVDR submissions

Cross-functional collaboration

Project management

Formation

Bachelor's degree in life science or related field

Description du poste

• 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.