Regulatory Affairs Advisor

Regulatory Affairs Advisor plays a key role in supporting the development of regulatory strategy for Natera's products and services, combining strong technical knowledge and understanding of regulatory requirements to support approval and registration.

Requirements

• Develops and executes aggressive regulatory strategies for complex regulatory affairs programs
• Coordinates and prepares regulatory submissions, including EU/IVD Technical Documentation and 510(k) premarket notifications
• Evaluates product changes for impact to regulatory submissions globally
• Reviews and ensures regulatory compliance of advertising, promotion and labeling
• Represents the function on designated teams and may represent RA in different core teams and change control initiatives

Benefits

• Comprehensive medical, dental, vision, life and disability plans
• Free testing and fertility care benefits
• 401k benefits
• Commuter benefits
• Pregnancy and baby bonding leave
• Employee referral program