Regulatory Affairs Advisor
Natera · Remote
The apply link worked recently (not employer-confirmed).
Role summary
Natera seeks a Regulatory Advisor to lead FDA Pharma and IVDR regulatory strategy for genetic testing and liquid biopsy products. The role involves developing submission strategies, managing regulatory interactions with authorities, and mentoring team members in a remote position focused on diagnostic innovation.
Where this listing comes from
This listing was compiled by RoleLantern from the employer's publicly available posting on Greenhouse, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-03 (originally posted 2026-10-03). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.
What they're looking for
- Expertise in FDA regulations, IVDR, CAP/CLIA, and diagnostic device classification
- Experience preparing 510(k) submissions, IVD technical documentation, and pre-submissions
- Strong knowledge of regulatory pathways for in vitro diagnostic systems and pharma approvals
- Demonstrated ability to represent regulatory function with internal and external stakeholders
- Experience mentoring regulatory staff and leading cross-functional compliance initiatives
What you'll be doing
- Develop and execute regulatory strategies for FDA Pharma, IVDR, and IVD submission programs
- Prepare and coordinate regulatory submissions including 510(k)s, technical documentation, and worldwide registrations
- Conduct stakeholder communications with regulatory authorities regarding pathways, claims, and labeling
- Mentor regulatory associates and deliver training on regulatory topics across teams
- Assess product changes for global regulatory impact and ensure promotional compliance
Privacy & handoff
This role links to Natera's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.