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.

• Manage multiple projects with urgency, staying organized and focused on delivering results.

• Demonstrated ability to effectively formulate and drive change.

• Experienced in continuous improvement projects, project management, and product development processes.

• Thrive in ambiguity by navigating rapid change and actively building structure and standard operating procedures where they are missing.

• Excellent written and verbal communication skills, including the ability to communicate across cultures, work effectively with technical and scientific personnel, and negotiate clearly with Regulators.

• Computer literacy (PC, Microsoft Word/Excel/PowerPoint).