Job Description

Natera seeks a Senior Regulatory Affairs Specialist to develop and manage regulatory submissions for medical devices and in vitro diagnostics across domestic and international markets. The role involves interpreting regulatory requirements, preparing FDA submissions, and guiding product development teams through compliance processes.

Responsibilities

• Interpret U.S. and international medical device and IVD regulatory requirements for product teams
• Develop submission strategies and prepare 510(k)s, PMAs, IDEs, and pre-submission documentation
• Review clinical protocols and study data to ensure regulatory compliance and appropriateness
• Coordinate responses to regulatory agency requests and negotiate with FDA
• Review labels, labeling, and promotional materials for regulatory compliance

Requirements

• Bachelor's degree in biological sciences, chemistry, or related field
• Minimum 5 years experience in device, diagnostic, biologic, or pharmaceutical industry
• Knowledge of U.S. medical device and IVD regulatory requirements, GLP, and QSR
• Knowledge of European Medical Device and IVD Directive requirements
• Strong verbal and written communication skills
• Project management experience

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