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Product Manager - Diagnostics
Product Manager - DiagnosticsPluslife • San Diego, CA, United States
Product Manager - Diagnostics

Product Manager - Diagnostics

Pluslife • San Diego, CA, United States
13 hours ago
Job type
  • Full-time
Job description

About Pluslife

Pluslife is a global molecular-diagnostics innovator transforming how infectious diseases are detected and monitored. Our assays and platforms are trusted in 40 + countries through collaborations with WHO, FIND, and the Gates Foundation.

We are now expanding our U.S. operations to bring  affordable, clinically reliable, and regulatorily compliant testing closer to patients, clinicians, and veterinary professionals.

The Role

We’re seeking a  Product Manager with hands-on diagnostics or medical-device experience  who thrives on translating clinical and laboratory needs into market-ready solutions. You’ll connect assay development, engineering, regulatory, and commercial teams to ensure each product meets scientific, operational, and business standards for success.

You’ll work across human and veterinary health programs, helping Pluslife build a portfolio that delivers clinical confidence and commercial scalability.

What You’ll Do

  • Own product lifecycle  from concept through regulatory submission and launch (feasibility → V&V → clinical validation → market release).
  • Collaborate with R&D, QA / RA, and manufacturing teams to define requirements, design transfer criteria, and risk-management documentation (e.g., ISO 13485, FDA QSR).
  • Partner with clinicians, veterinarians, and laboratory stakeholders to identify workflow pain points and translate them into user and product requirements.
  • Conduct structured market and competitor analyses for diagnostic assays and POC systems.
  • Support regulatory and clinical trial planning (510(k), CLIA-waived, EUA, or USDA-CVB for vet tests).
  • Define commercialization readiness : labeling, instructions-for-use, training, post-market feedback loops.
  • Build internal documentation and processes that strengthen Pluslife’s product-development discipline in the U.S.

Who You Are

  • 3–7 years experience in  diagnostics, medical devices, or life-science product management .
  • Familiar with  FDA / IVD regulations, ISO 13485, or CLIA environments.
  • Comfortable bridging  scientific detail, clinical workflow, and business decision-making.
  • Experience collaborating with  cross-functional teams  (R&D, RA / QA, clinical affairs, manufacturing, sales).
  • Strong written and verbal communication suited to clinicians, engineers, and executives.
  • Analytical and structured, yet pragmatic — focused on measurable progress over theory.
  • Exposure to  veterinary, public-health, or POC diagnostics  programs.

    • Why Join Pluslife

  • Shape the U.S. foundation of a global diagnostics company.
  • Direct access to founders and executives — your work drives regulatory and commercial milestones.
  • Operate with autonomy inside a small, expert team that values scientific integrity and operational clarity.
  • Equity participation and long-term career growth as Pluslife expands.

    • How to Apply

    Send your LinkedIn profile and resume along with a brief note answering :

    “Describe a time you translated a clinical or laboratory requirement into a commercially viable diagnostic product.”

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    Product Manager • San Diego, CA, United States