Remote Senior Program Manager, Diagnostics & CDx

Natera; United States; Hybrid; USD 119,000 - 149,000; Full time

Benefits offered by this job

Health benefits

401(k) with company match

Paid time off

Work-life benefits

Job summary

Natera is seeking a Senior Program Manager to lead complex diagnostic and medical device product development programs from early development through regulatory submission and product lifecycle activities. You will partner with R&D, Software, Quality, Regulatory, Clinical, and Operations to drive milestones, manage risk, and ensure IDE/IVDR/510(k) readiness in a fast-paced, regulated environment.

The role requires 5–7+ years in program management or related fields, with deep ISO 13485/IEC 62304

Qualifications

• Experience leading cross-functional diagnostic/medical device programs.
• Strong understanding of regulated product development processes.
• Hands-on experience with DDPs, DHF, and regulatory deliverables.

Responsibilities

• Lead cross-functional product development programs and core teams.
• Drive milestones, design reviews, clinical launch, and regulatory readiness.
• Translate goals into clear plans and decisions for teams.
• Identify risks, dependencies, and drive governance decisions.
• Coordinate regulatory submissions (IDE, IVDR, 510(k), PMA) activities.
• Ensure design controls, risk management, verification/validation documentation.

Skills

Cross-functional leadership

Regulatory submissions

ISO 13485

IEC 62304

Program management

IVD development

PMP (preferred)

Education

Bachelor's degree in life sciences or engineering

PMP certification (preferred)

Job description

Natera is seeking a Senior Program Manager to lead complex diagnostic and medical device product development programs from early development through regulatory submission and product lifecycle activities. You will partner with R&D, Software, Quality, Regulatory, Clinical, and Operations to drive milestones, manage risk, and ensure IDE/IVDR/510(k) readiness in a fast-paced, regulated environment.

The role requires 5–7+ years in program management or related fields, with deep ISO 13485/IEC 62304