Senior Program Manager

Natera
Boulder
Workplace: HybridFull timeUSD 119,000 - 148,700 annuallyFunction: Program & Project Management (PMO)Experience: 5+ yearsSkills: ["Communication","Problem-solving","Judgment","Influencing without authority","Risk management"]

Lead complex, cross-functional product development programs for diagnostic and medical device initiatives from early development through clinical trial launch, regulatory submission, and lifecycle activities. You’ll coordinate R&D, Software, Quality, Regulatory, Clinical, and Operations teams, drive milestone execution and design reviews, manage risks and dependencies, and author key documentation such as DDPs and DHF materials. Support IDE, IVDR, and 510(k) readiness and CDx assay alignment.

Loading

Loading job details...

Preparing the role view and application actions.

FursaFursa
Natera
Natera
4 months ago

Senior Program Manager

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI
Last checked: 3 minutes agoStatus: Live

Job Summary

Lead complex, cross-functional product development programs for diagnostic and medical device initiatives from early development through clinical trial launch, regulatory submission, and lifecycle activities. You’ll coordinate R&D, Software, Quality, Regulatory, Clinical, and Operations teams, drive milestone execution and design reviews, manage risks and dependencies, and author key documentation such as DDPs and DHF materials. Support IDE, IVDR, and 510(k) readiness and CDx assay alignment.
Location: Boulder
Workplace: Hybrid
Employment Type: Full time
Job Function: Program & Project Management (PMO)
Seniority: Manager level

Key Responsibilities

  • •Lead complex, cross-functional product development programs as program leader across R&D, Software, Quality, Regulatory, Clinical, and Operations.
  • •Drive programs through development milestones, design reviews, phase exits, clinical trial launch, FPI, and regulatory submission readiness.
  • •Translate product goals and regulatory requirements into plans, priorities, and decisions that enable execution.
  • •Resolve technical, operational, and organizational issues; identify and manage risks, dependencies, and trade-offs, and escalate through portfolio governance when needed.
  • •Author and review core deliverables including DDPs, DHF documentation, design review materials, and change orders; coordinate IDE/IVDR/510(k) submission deliverables and support CDx assay alignment.

Pay and Benefits

Salary: USD 119,000 - 148,700 annually
Perks:Health InsuranceDentalVision401kPaid Leave

Key Requirements

  • •5–7+ years of experience in program management and product development (or related program leadership) in diagnostics, medical devices, biotechnology, clinical laboratories, or life sciences.
  • •Significant experience leading complex, cross-functional product development programs in a regulated environment.
  • •Deep practical understanding of ISO 13485, IEC 62304, and design controls for regulated medical device/IVD development.
  • •Hands-on experience with product development documentation, including DDPs and DHF documentation, plus change orders and risk documentation.
  • •Experience supporting regulatory submissions such as IDE, IVDR, 510(k), or PMA.
Experience:5+ yearsDiagnosticsMedical devicesBiotechnologyClinical laboratoriesLife sciences
Skills:CommunicationProblem-solvingJudgmentInfluencing without authorityRisk management
Certifications:PMP
Tech Stack:ISO 13485IEC 62304Design controlsDHF documentationDHFDDPsChange ordersRisk documentationDesign review materialsIDEIVDR510(k)PMACDxNGSCell-free DNAMRDRegulatory submissionsPortfolio governanceFPI

Company Brief

Natera
Develops and commercializes genetic testing and diagnostics focused on reproductive health, oncology, and organ transplant to inform clinical decision-making and improve patient outcomes.
Industry: Diagnostics
Company Size: Enterprise (1,001+ employees)
Revenue: USD 500M to 1B
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: San Carlos, United States
Founded: 2004
WebsiteLinkedIn