Natera is seeking a Regulatory Affairs Advisor to support regulatory strategy and submissions for its products and services, particularly focusing on IVD systems. The ideal candidate will have extensive regulatory experience in medical devices and strong leadership skills, with a preference for those holding advanced degrees or certifications
Job Summary
Plays a key role in supporting the development of regulatory strategy on behalf of the regulatory affairs team across Natera’s products and services.
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.
Leads cross-functional or cross-business teams to address process improvements, major regulatory changes or initiatives.
Matching Summary
Match Score: 85
Natera is seeking a Regulatory Affairs Advisor to support regulatory strategy and submissions for its products and services, particularly focusing on IVD systems. The ideal candidate will have extensive regulatory experience in medical devices and strong leadership skills, with a preference for those holding advanced degrees or certifications.
Skills & Requirements
Must-have
regulatory strategy development
IVD systems regulatory submissions
EU/IVD Technical Documentation
510(k) premarket notifications
post-market surveillance reports
regulatory compliance
Nice-to-have
least burdensome approaches
cross-functional team leadership
mentoring regulatory associates
process improvement contributions
Key Requirements
12 years of direct applicable regulatory experience