← All roles

Regulatory Affairs Advisor

Natera· Regulatory Affairs
Apply on company site
Remote$146.1k - $182.6kfull-timePosted 2w ago

About the role

Regulatory Advisor focusing on FDA Pharma and IVDR initiatives to support product approvals, registrations, and regulatory strategy for Natera’s diagnostics offerings in a US remote role.

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.

Skills

Required:Regulatory strategyRegulatory submissionsCross-functional leadershipRegulatory compliance
Last updated Oct 8, 2026. Interested? Apply on the company site.

About Natera

A global leader in cfDNA testing

Dedicated to oncology, women’s health, and organ health. Natera’s cell-free DNA tests help protect health and inform more personalized decisions about care.

oncologywomen's healthorgan healthcell-free DNA
Company profileWebsite

More open roles at Natera