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Ivd Product Manager Jobs (NOW HIRING)

DiaSorin

Senior Product Manager, Molecular

California, MO · On-site

$143 - $175/hr

  • Medical

  • Retirement

Job Scope The Senior Global Product Manager, IVD for targeted molecular assays will be responsible and accountable for the product management activities supporting innovation, product development and ...

DiaSorin

Senior Product Manager, Molecular

Cypress, CA · On-site

$143K - $175K/yr

  • Medical

  • Retirement

Job Scope The Senior Global Product Manager, IVD for targeted molecular assays will be responsible and accountable for the product management activities supporting innovation, product development and ...

DiaSorin

Senior Product Manager, Molecular

Cypress, CA · On-site

$143K - $175K/yr

  • Medical

  • Retirement

Job Scope The Senior Global Product Manager, IVD for targeted molecular assays will be responsible and accountable for the product management activities supporting innovation, product development and ...

CorDx

Regulatory & Compliance Specialist

San Diego, CA

$90K - $95K/yr

  • Medical

  • Retirement

  • PTO

... 510K) for IVD products. Requirements * Education: * Bachelor's degree in a related field (e.g., Life Sciences, Engineering, Regulatory Affairs, Quality Management) or equivalent experience.

Nova Biomedical

Principal Design Quality Engineer I

Waltham, MA · On-site

$120K - $160K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

... Management System, with a focus on design-related processes. * Participate in internal and external audits, providing subject matter expertise on design controls and IVD product development.

Quanterix

Sr. Director, Assay Development

Billerica, MA

$225K - $265K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

... Management, Product Management, Manufacturing, QC and QA to ensure successful assay progress though Product Development, Transfer to manufacturing, and IVD submissions. * Drive highest possible ...

Natera

Design Transfer Scientist

San Carlos, CA · Hybrid

... IVD) Next-Generation Sequencing (NGS) assays from R&D into scalable clinical operations. This role ... Lead risk management activities, including FMEAs, to identify and mitigate potential product risks ...

Nova Biomedical

Principal Design Quality Engineer I

Waltham, MA · Hybrid

$120K - $160K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

... Management System, with a focus on design-related processes. * Participate in internal and external audits, providing subject matter expertise on design controls and IVD product development.

QUANTERIX CORP

Sr. Director, Assay Development

Billerica, MA · On-site

$225K - $265K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

... Management, Product Management, Manufacturing, QC and QA to ensure successful assay progress though Product Development, Transfer to manufacturing, and IVD submissions. * Drive highest possible ...

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All JobsIvd Product JobsIvd Product Manager Jobs

Ivd Product Manager information

See salary details

$51.5K

$159.4K

$197K

How much do ivd product manager jobs pay per year?

As of Aug 16, 2026, the average yearly pay for ivd product manager in the United States is $159,405.00, according to ZipRecruiter salary data. Most workers in this role earn between $141,000.00 and $197,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as an IVD product manager, and why are they important?

To thrive as an IVD Product Manager, you need a strong background in life sciences, product management experience, and knowledge of regulatory requirements such as IVDR or FDA, often supported by a bachelor's or advanced degree in a scientific field. Familiarity with product lifecycle management tools, CRM software, and regulatory documentation systems is typically required. Excellent communication, cross-functional collaboration, and strategic thinking are standout soft skills for this role. These skills and qualifications ensure that products are effectively developed, compliant, and successfully brought to market in the highly regulated IVD industry.

What is an IVD product manager?

An IVD (In Vitro Diagnostics) Product Manager is responsible for overseeing the development, marketing, and lifecycle management of products used to diagnose diseases or conditions through biological samples, such as blood or tissue, outside the human body. They work closely with R&D, regulatory, marketing, and sales teams to ensure products meet market needs and comply with relevant regulations. IVD Product Managers play a critical role in defining product strategy, launching new products, and ensuring customer satisfaction in the diagnostics industry.

What are some common challenges IVD product managers face when launching new diagnostic products?

IVD Product Managers often navigate complex regulatory requirements, such as FDA or CE approval, which can lengthen timelines and require thorough documentation. Another challenge is coordinating cross-functional teams, including R&D, quality assurance, and marketing, to ensure product specifications meet both clinical needs and compliance standards. Additionally, staying updated with rapidly evolving technologies and competitor products is essential to position the diagnostic solution effectively in the market. Effective communication and agile project management are key to overcoming these hurdles.

What is the difference between Ivd Product Manager vs Ivd Quality Assurance Specialist?

AspectIvd Product ManagerIvd Quality Assurance Specialist
CredentialsBachelor's degree in life sciences, engineering, or related field; often an MBA or product management certificationBachelor's degree in biology, chemistry, or related field; quality assurance certifications like CQE are common
Work EnvironmentCross-functional teams, product development, market analysisLaboratories, quality control departments, compliance testing
Industry UsageUsed in medical device companies, biotech firms, and diagnostics manufacturersCommon in manufacturing, biotech, and medical device companies ensuring product safety

The Ivd Product Manager focuses on product development, strategy, and market success, while the Ivd Quality Assurance Specialist ensures product safety, compliance, and quality standards. Both roles are essential in the IVD industry but serve different functions within the product lifecycle.

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Ivd Product Manager jobs near you
Infographic showing various Ivd Product Manager job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 86% Full Time, 12% Part Time, and 1% Contract. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $159,405 per year, or $76.6 per hour.

Analytical Chemist &ndash

Noblesoft Technologies

Des Plaines, IL • On-site

Contractor

Re-posted 24 days ago

Job description

Job Title: Analytical Chemist – Ion Chromatography & HPLC
Location: Des Plaines, Illinois
 

Key Responsibilities:
  • Develop and validate IC and HPLC methods for the characterization of raw materials, buffers, and critical reagents used in IVD assays.
  • Support reagent and assay development teams by providing analytical data to guide formulation, stability, and performance optimization.
  • Operate, maintain, and troubleshoot analytical instrumentation, including IC and HPLC systems with various detectors (e.g., UV, conductivity, MS).
  • Design and execute method robustness and transfer studies to support product development,  tech transfer, lifecycle management, and regulatory submissions
  • Generate and review technical documentation, including protocols, validation reports, and SOPs, in compliance with IVD regulatory standards (e.g., FDA, ISO 13485, CLSI).
  • Collaborate with R&D, Quality, and Manufacturing teams to support product development, process validation, and root cause investigations.
  • Interpret complex analytical data and generate technical reports, protocols, and SOPs in
  • Ensure compliance with regulatory guidelines (FDA, ICH, USP, etc.) and internal quality systems.
  • Train and mentor junior staff in analytical techniques and instrumentation best practices.
 
 
Qualifications:
  • Bachelor’s, Master’s, or Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, or a related field.
  • 5+ years of hands-on experience in IC and HPLC method development, preferably in the IVD, medical device, or pharmaceutical industry.
  • Strong understanding of analytical method validation in a regulated environment (FDA, ISO 13485, ICH).
  • Proficiency with analytical software (e.g., Chromeleon, Empower, ChemStation) and data integrity principles.
  • Familiarity with IVD assay components, such as enzymes, antibodies, and buffers, is highly desirable.
  • Excellent documentation, communication, and problem-solving skills.
 
 
Preferred Skills:
  • Experience with biologics, enzymes, or complex matrices.
  • Familiarity with other analytical techniques such as GC, CE, or spectroscopy.
  • Knowledge of data integrity principles and electronic laboratory systems (e.g., LIMS, ELN).
  • Knowledge of design control and risk management in the context of IVD product development.
  • Prior experience supporting 510(k) or PMA submissions is a plus