[Hiring] Regulatory Affairs Advisor @Natera

Role Description

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. 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.

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.

Requirements

• 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).

Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
• Free testing for Natera employees and their immediate families, in addition to fertility care benefits.
• Pregnancy and baby bonding leave.
• 401k benefits.
• Commuter benefits.
• Generous employee referral program.

Company Description

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.