Regulatory Affairs Advisor

POSITION SUMMARY 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. PRIMARY RESPONSIBILITIES - 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. QUALIFICATIONS - 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. KNOWLEDGE, SKILLS, AND ABILITIES - 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 make decisions even when rigid policies do not exist .