<p> </p> <p data-path-to-node="13"><strong data-path-to-node="13" data-index-in-node="0">POSITION SUMMARY</strong></p> <p data-path-to-node="13"><strong data-path-to-node="13" data-index-in-node="17">Title:</strong> Regulatory Advisor - FDA Pharma & IVDR</p> <p id="p-rc_93e39727a0f27b67-101" data-path-to-node="14"><span data-path-to-node="14,0">Natera is a clinical genetic testing company specializing in non-invasive, cell-free DNA (cfDNA) and liquid biopsy testing</span><span data-path-to-node="14,2">. 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</span><span data-path-to-node="14,4">. 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</span><span data-path-to-node="14,6">.</span></p> <p data-path-to-node="15">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.</p> <p data-path-to-node="16"><strong data-path-to-node="16" data-index-in-node="0">PRIMARY RESPONSIBILITIES</strong></p> <ul data-path-to-node="17"> <li> <p data-path-to-node="17,0,0">Represent the regulatory function on designated cross-functional teams.</p> </li> <li> <p data-path-to-node="17,1,0">Conduct business interactions with customers and regulatory authorities regarding regulatory pathways, performance claims, supporting data, and labeling in the context of submissions or registrations.</p> </li> <li> <p data-path-to-node="17,2,0">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.</p> </li> <li> <p data-path-to-node="17,3,0">Advocate for the least burdensome approaches to product clearance and approval while strictly interpreting and adhering to regulatory requirements.</p> </li> <li> <p data-path-to-node="17,4,0">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.</p> </li> <li> <p data-path-to-node="17,5,0">Mentor regulatory associates and support their career advancement.</p> </li> <li> <p data-path-to-node="17,6,0">Deliver training on regulatory topics across internal teams.</p> </li> <li> <p data-path-to-node="17,7,0">Lead cross-functional teams to address major regulatory changes, compliance with new registration requirements, or process improvements.</p> </li> <li> <p data-path-to-node="17,8,0">Contribute to setting individual and departmental annual goals aligned with business objectives.</p> </li> <li> <p data-path-to-node="17,9,0">Review and ensure regulatory compliance of advertising, promotion, and labeling across a common product line.</p> </li> <li> <p id="p-rc_93e39727a0f27b67-102" data-path-to-node="17,10,0"><span data-path-to-node="17,10,0,0">Take personal accountability for identifying gaps in processes and proactively build data-driven solutions to improve them</span><span data-path-to-node="17,10,0,2">.</span></p> </li> <li> <p data-path-to-node="17,11,0">Evaluate product changes for global regulatory submission impact.</p> </li> <li> <p data-path-to-node="17,12,0">May lead small teams.</p> </li> <li> <p data-path-to-node="17,13,0">Other duties as assigned.</p> </li> </ul> <p data-path-to-node="18"><strong data-path-to-node="18" data-index-in-node="0">QUALIFICATIONS</strong></p> <ul data-path-to-node="19"> <li> <p data-path-to-node="19,0,0">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.</p> </li> <li> <p data-path-to-node="19,1,0">Regulatory Affairs Certification (RAC) preferred.</p> </li> <li> <p data-path-to-node="19,2,0">Minimum of 8+ years of direct applicable regulatory experience in medical devices, laboratory-developed tests (LDTs), or pharma.</p> </li> <li> <p data-path-to-node="19,3,0">Direct experience with FDA Pharma and IVDR submissions is highly preferred.</p> </li> <li> <p data-path-to-node="19,4,0">Experience in Organ Health or Women's Health diagnostics is ideal and strongly preferred.</p> </li> <li> <p data-path-to-node="19,5,0">In Vitro Diagnostics (IVD) and Companion Diagnostics (CDx) experience is a plus.</p> </li> <li> <p data-path-to-node="19,6,0">PMA experience preferred.</p> </li> </ul> <p data-path-to-n