Remote Regulatory Advisor — FDA/IVDR for Diagnostics

Natera, Inc.; United States, Northern America, Americas; Hybrid; USD 146,000 - 183,000; Full time

Benefits offered by this job

Comprehensive medical, dental, vision

Life and disability plans

Free testing for employees and depend

Pregnancy leave

401k benefits

Commuter benefits

Generous employee referral program

Job summary

Natera, Inc. is seeking a Regulatory Advisor to drive regulatory strategy for FDA Pharma and IVDR initiatives. You will represent the RA team to internal and external stakeholders, manage registrations, and contribute to staff development and process improvements across global regulatory requirements.

The role emphasizes leadership in cross-functional teams, regulatory submissions, and ensuring compliance while supporting evolving diagnostics regulations worldwide.

Qualifications

• 8+ years of direct regulatory experience in medical devices, LDTs, or pharma.
• Direct experience with FDA Pharma and IVDR submissions.
• Experience in Organ Health or Women's Health diagnostics preferred.
• IVD and CDx experience is a plus.
• PMA experience preferred.

Responsibilities

• Represent Regulatory on cross-functional teams and liaise with stakeholders.
• Coordinate regulatory submissions (EU/IVD/IVDR, 510(k), NYS DoH, etc.).
• Develop bold regulatory strategies for FDA Pharma and IVDR programs.
• Advocate least-burdensome approaches while adhering to requirements.
• Mentor associates and support their career development.
• Deliver regulatory training across internal teams.
• Lead teams through major regulatory changes and process improvements.
• Review advertising, promotion and labeling for regulatory compliance.

Skills

Regulatory strategy

FDA Pharma

IVDR

Regulatory submissions

Cross-functional collaboration

Mentoring

Communication

Process improvement

Education

Bachelor’s degree in life sciences or equivalent

Advanced degree (MS/PhD) and/or MBA preferred

Regulatory Affairs Certification (RAC) preferred

Job description

Natera, Inc. is seeking a Regulatory Advisor to drive regulatory strategy for FDA Pharma and IVDR initiatives. You will represent the RA team to internal and external stakeholders, manage registrations, and contribute to staff development and process improvements across global regulatory requirements.

The role emphasizes leadership in cross-functional teams, regulatory submissions, and ensuring compliance while supporting evolving diagnostics regulations worldwide.