Natera · 9 hours ago
Senior Regulatory Affairs Specialist
United States
Full-time
Remote
Mid, Senior Level
$88K/yr - $110K/yr
4+ years expNatera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. The Senior Regulatory Affairs Specialist plays a key role in supporting the effective implementation of regulatory strategy across Natera’s products and services, ensuring compliance and managing communications with regulatory authorities.
BiotechnologyGeneticsHealth DiagnosticsMedicalWomen's
Responsibilities
Support preparation of pre-submissions to regulatory authorities providing guidance to teams on regulatory strategy and requirements; Work closely with RA leadership to prepare analytical and clinical pre-submissions that advance project goals
Support regulatory submissions for in vitro diagnostic devices including IDEs, EU/IVD Technical Documentation, classification requests, pre-submissions, and updates to registrations worldwide
Contribute to the setting of individual and departmental annual goals aligned with business objectives
Review and ensure regulatory compliance of advertising, promotion and labeling across a common product line
Support regulatory affairs efforts in new and existing technology project teams to implement regulatory strategy and meet regulatory requirements towards overall success of the project deliverables. Support regulatory initiatives within regulatory affairs
Represent Regulatory Affairs in written communication with regulatory authorities
Contribute to regulatory plans and regulatory change assessments that meet CAP/CLIA/NYS, US IVD, EU IVDR and international requirements
Collaborate within the RA team to implement least-burdensome approaches and facilitate time-to-market for Natera products and services
Understand and implement regulatory strategy based on existing guidance documents within a particular area of IVDs either CLIA/CAP/NYS, US FDA or EU IVDR. Provide summaries and educational awareness within project sub-teams or in support of project planning
Support regulatory deliverables on behalf of internal and external program teams
Build specialized knowledge of regulatory guidelines and requirements within one or more fields applicable to Natera; maintain excellent records of regulatory interactions and reports, contribute to the effectiveness of the RA team
Support RA leadership in implementation of data-driven improvements in RA processes, acquisition of cross-functional leadership skills and core competencies in regulatory affairs
Other duties as assigned
Qualification
Required
4-6 years biotech industry experience
Associate's Degree / certificate, B.A., B.S., or equivalent. Work experience may be considered in lieu of education
Benefits
Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
Free testing in addition to fertility care benefits
Pregnancy and baby bonding leave
401k benefits
Commuter benefits
Generous employee referral program
Company
Natera
Natera specializes in cell-free DNA testing to provide a more targeted interventions to oncology, women's health, and organ health.
5001-10000 employees
H1B Sponsorship
Natera has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (64)
2024 (72)
2023 (37)
2022 (71)
2021 (64)
2020 (40)
Funding
Current Stage
Public CompanyTotal Funding
$1.16BKey Investors
Sofinnova InvestmentsLightspeed Venture PartnersSequoia Capital
2023-09-07Post Ipo Equity· $250M
2022-11-15Post Ipo Equity· $400.05M
2022-03-16Post Ipo Equity· $5M
Leadership Team
Steve Chapman
CEO
Jonathan Sheena
Co-Founder, Board Member
Recent News
2025-12-16
Company data provided by crunchbase