Regulatory Strategy Lead: FDA & IVDR Submissions

Natera; San Carlos (CA); Remote; USD 146,000 - 183,000; Full time

Benefits offered by this job

Medical, dental, vision

Life and disability plans

401k benefits

Commuter benefits

Job summary

Natera is seeking a Regulatory Advisor focused on FDA Pharma and IVDR to drive regulatory strategy across programs and geographies. You will coordinate submissions, mentor staff, and partner with cross-functional teams to ensure compliant product registrations and labeling.

This role requires deep knowledge of US FDA, EU IVDR, and IVD/LDT standards and a proactive, data-driven approach.

Qualifications

• Bachelor’s degree in a life science field ... Advanced degree preferred.
• Regulatory Affairs Certification (RAC) preferred.
• Minimum of 8+ years of direct regulatory experience in medical devices, LDTs, or pharma.
• Direct experience with FDA Pharma and IVDR submissions is highly preferred.

Responsibilities

• Represent the regulatory function on designated cross-functional teams.
• Interact with customers and regulators on regulatory pathways and labeling.
• Develop regulatory strategies for FDA Pharma, IVDR, and IVD systems.
• Advocate least burdensome approaches to clearance and approval.
• Coordinate regulatory submissions (EU/IVD/IVDR, 510(k), NYS, etc.).
• Mentor regulatory associates and support career development.
• Deliver training on regulatory topics across teams.
• Lead cross-functional teams through major regulatory changes.
• Contribute to departmental goals and process improvements.
• Ensure advertising and labeling compliance across products.
• Identify gaps and build data-driven process improvements.
• Evaluate product changes for global submission impact.
• May lead small teams.

Skills

Stakeholder comms

Regulatory strategy

Project management

Analytical thinking

Cross-functional collab

Change management

Education

Bachelor's in life sciences

Advanced degree (MS/PhD)

RAC preferred

Job description

Natera is seeking a Regulatory Advisor focused on FDA Pharma and IVDR to drive regulatory strategy across programs and geographies. You will coordinate submissions, mentor staff, and partner with cross-functional teams to ensure compliant product registrations and labeling.

This role requires deep knowledge of US FDA, EU IVDR, and IVD/LDT standards and a proactive, data-driven approach.