Plays a key role in supporting the development of regulatory strategy on behalf of the regulatory affairs team across Natera’s products and services. Combines strong technical knowledge and understanding of regulatory requirements within at least one regional expertise, e.g. US FDA, CAP/CLIA/NYS, EU, or Japan to support the approval and registration of Natera’s products and services.
Represents the RA team to internal and external stakeholders through written and verbal communication within at least one product line. May represent RA in different core teams and change control initiatives. Maintains product registrations, change assessments and post-market surveillance reports and records of communication with regulatory authorities. Supports overall effectiveness of the regulatory affairs team at Natera through contributions to staff development, process improvements and understanding of current regulatory requirements.
Strategy & Submissions
Develops and executes aggressive strategies weighted with realistic regulatory objectives for a range of complex regulatory affairs programs with emphasis on requirements and submissions associated with IVD systems (hardware, software, reagents, etc.).
Coordinates and prepares regulatory submissions with minimum supervision, including EU/IVD Technical Documentation, classification requests, pre-submissions, 510(k) premarket notifications, investigational device exemptions, NYS DoH submissions, and critical registrations worldwide.