Regulatory Affairs Advisor US Remote

Title: Regulatory Advisor - FDA Pharma & IVDR

Natera is a clinical genetic testing company specializing in non-invasive, cell-free DNA (cfDNA) and liquid biopsy testing . The Regulatory Advisor plays a key role in developing and driving regulatory strategy on behalf of the regulatory affairs (RA) team, specifically focusing on FDA Pharma and IVDR initiatives. At Natera, we remember there is a person behind every sample . This role combines strong technical knowledge and an understanding of regulatory requirements (US FDA, CAP/CLIA/NYS, EU, or Japan) to support the approval and registration of products that proactively inform disease management .

You will represent the RA team to internal and external stakeholders through written and verbal communication. This role maintains product registrations, change assessments, post-market surveillance reports, and records of communication with regulatory authorities. You will support the overall effectiveness of the RA team through contributions to staff development, process improvements, and maintaining a deep understanding of current regulatory requirements in the evolving diagnostics landscape.

• Represent the regulatory function on designated cross-functional teams.
• Conduct business interactions with customers and regulatory authorities regarding regulatory pathways, performance claims, supporting data, and labeling in the context of submissions or registrations.
• Build and execute bold, practical regulatory strategies for complex regulatory affairs programs, with a heavy emphasis on FDA Pharma, IVDR, and In Vitro Diagnostic (IVD) systems.
• Advocate for the least burdensome approaches to product clearance and approval while strictly interpreting and adhering to regulatory requirements.
• Coordinate and prepare regulatory submissions with minimal supervision, including EU/IVD/IVDR Technical Documentation, classification requests, pre-submissions, 510(k) premarket notifications, investigational device exemptions, NYS DoH submissions, and critical worldwide registrations.
• Mentor regulatory associates and support their career advancement.
• Deliver training on regulatory topics across internal teams.
• Lead cross-functional teams to address major regulatory changes, compliance with new registration requirements, or process improvements.
• Contribute to setting individual and departmental annual goals aligned with business objectives.
• Review and ensure regulatory compliance of advertising, promotion, and labeling across a common product line.
• Take personal accountability for identifying gaps in processes and proactively build data-driven solutions to improve them .
• Evaluate product changes for global regulatory submission impact.
• May lead small teams.
• Other duties as assigned.

• Bachelor’s degree in a life science field (biology, microbiology, chemistry, engineering, medical technology, regulatory science, etc.) or equivalent. Advanced degree in life sciences (MS, PhD, etc.) and/or MBA preferred.
• Regulatory Affairs Certification (RAC) preferred.
• Minimum of 8+ years of direct applicable regulatory experience in medical devices, laboratory-developed tests (LDTs), or pharma.
• Direct experience with FDA Pharma and IVDR submissions is highly preferred.
• Experience in Organ Health or Women's Health diagnostics is ideal and strongly preferred.
• In Vitro Diagnostics (IVD) and Companion Diagnostics (CDx) experience is a plus.
• PMA experience preferred.

• Working knowledge of U.S. and EU Medical Device/IVD/IVDR, FDA Pharma, and/or laboratory developed test regulatory requirements.
• Proactive, self-directed, and highly engaged.
• Emphasis on talent development and team building.
• Use sound scientific judgment to solve problems and…