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Ivd Product Manager Jobs (NOW HIRING)

Natera

Scientist, IVD Product Development

San Carlos, CA · On-site

$116K - $146K/yr

Manage assigned technical projects and associated timelines and deliverables in NGS-based assays ... Experience with IVD product development and design controls. Knowledge, Skills, and Abilities:

CorDx

IVD Laboratory Technician

Alpharetta, GA · On-site

$18.50 - $24.75/hr

Execute routine and non-routine testing to support product development, verification, validation ... Contribute to design inputs, design outputs, risk management activities, and design change ...

CorDx

IVD Laboratory Technician

Alpharetta, GA · On-site

$18.50 - $24.75/hr

Execute routine and non-routine testing to support product development, verification, validation ... Contribute to design inputs, design outputs, risk management activities, and design change ...

CorDx

IVD Laboratory Technician

Alpharetta, GA · On-site

$18.50 - $24.75/hr

Execute routine and non-routine testing to support product development, verification, validation ... Contribute to design inputs, design outputs, risk management activities, and design change ...

CorDx

Regulatory Manager- IVD and 510(k)

San Diego, CA · On-site

$90K - $150K/yr

Onsite - San Diego Salary Range: $90000-$150000/Yearly Responsibilities • Prepare and submit 510(k) applications for IVD products to ensure timely market entry. • Manage all aspects of regulatory ...

CorDx

Regulatory Affairs Manager - IVD

San Diego, CA · On-site

... management of in vitro diagnostic (IVD) medical devices in the United States. The Regulatory ... Determine appropriate regulatory pathways, product classification, predicate devices, and ...

CorDx

Regulatory Affairs Manager - IVD

San Diego, CA · On-site

... management of in vitro diagnostic (IVD) medical devices in the United States. The Regulatory ... Determine appropriate regulatory pathways, product classification, predicate devices, and ...

CorDx

Regulatory Manager- IVD and 510(k)

San Diego, CA · On-site

$90K - $150K/yr

Onsite - San Diego Salary Range: $90000-$150000/Yearly Responsibilities Prepare and submit 510(k) applications for IVD products to ensure timely market entry. Manage all aspects of regulatory ...

CorDx

Regulatory Affairs Manager - IVD

San Diego, CA · On-site

... management of in vitro diagnostic (IVD) medical devices in the United States. The Regulatory ... Determine appropriate regulatory pathways, product classification, predicate devices, and ...

CorDx

Regulatory Manager- IVD and 510(k)

San Diego, CA · On-site

$90K - $150K/yr

Onsite - San Diego Salary Range: $90000-$150000/Yearly Responsibilities · Prepare and submit 510(k) applications for IVD products to ensure timely market entry. · Manage all aspects of regulatory ...

Qiagen

Senior Scientific Expert IVD

Germantown, MD · Hybrid

$82K - $120K/yr

... in product development up to lifecycle management for registered products * Lead R&D innovation ... Experience with IVD product development in a regulated environment recommended. * Experience with ...

CorDx

Regulatory Affairs Manager - IVD

San Diego, CA · On-site

$120 - $170/hr

... management of in vitro diagnostic (IVD) medical devices in the United States. The Regulatory ... Full‑Time Regulatory Strategy & Product Development * Develop and execute U.S. regulatory ...

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Ivd Product Manager information

See salary details

$51.5K

$159.4K

$197K

How much do ivd product manager jobs pay per year?

As of Sep 6, 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 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 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 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 87% Full Time, 12% Part Time, and 1% Contract. Highlights an 87% Physical, 2% Hybrid, and 11% Remote job distribution, with an average salary of $159,405 per year, or $76.6 per hour.

Scientist, IVD Product Development

Natera

San Carlos, CA

Full-time

Posted 18 days ago

Natera rating

7.8

Company rating: 7.8 out of 10

Based on 39 frontline employees who took The Breakroom Quiz

56th of 121 rated laboratories

Job description

Natera is a global leader in cell-free DNA testing. We measure fetal, tumor, or donor cfDNA at the molecular level to help inform personalized health care decisions with a non-invasive test.

We are looking for a highly motivated Scientist with a strong focus on process optimization and product verification studies to join the Early Cancer Detection product development team, joining a group of scientists who are tasked with developing and advancing Natera's oncology product portfolio.

The Scientist will be working with internal cross functional teams to develop IVD products. The ideal candidate is a driven professional who maintains broad knowledge of molecular biology and chemistry, and applies statistical principles to experiment design and analysis. The Scientist should have an in-depth understanding of design control methods and experience with current NGS oncology diagnostics devices. 

We are looking for a meticulous and proactive scientist with experience in both NGS-based assay development under design control and meant for submission to FDA and other regulatory bodies and who can work effectively in a fast-paced environment to ensure that the highest quality clinical assays are developed and launched for our patients.

Primary Responsibilities:

  • Design, develop, and validate automated high-throughput NGS assays that will be submitted to FDA and regulatory bodies, and be run in a commercial single-site IVD CLIA laboratory.

  • Manage assigned technical projects and associated timelines and deliverables in NGS-based assays. Mentor junior employees.

  • Design and execute moderate to high complexity experiments and perform basic data analysis (e.g. JMP, Excel).

  • Collaborate with other assay development scientists on the specifications of assay, reagent, equipment and quality metrics for future production assays.

  • Work with Clinical Laboratory and Quality Assurance to ensure that developed methods meet Natera's rigorous quality standards.

  • Coordinate with multiple internal groups (automation engineering, laboratory operations, bioinformatics, statistics, project and product management) and serve as point person to ensure the successful identification and timely execution of projects.

  • Write project protocols, reports and SOPs and train lab operations clinical lab scientists on procedures.

  • Plan and execute verification activities.

  • Identify areas for continuous improvement and actively contribute to the effort of introducing better practices to improve production workflows and shorten TAT for patient samples.

Minimum Qualifications:

  • BA/BS with 5+ years experience, MS with 3+ years or PhD with 1+ years experience in assay development and automation for the life science industry.  

  • Demonstrated track record of development and validation of automated protocols for CLIA labs.

  • Experience with IVD product development and design controls.

Knowledge, Skills, and Abilities:

  • Strong understanding of the chemistry underlying nucleic acid extraction, PCR, NGS library preparation, and hybrid capture technologies

  • Hands-on experience in reagent preparation and quality control for NGS-based assays

  • Experience implementing, optimizing, and troubleshooting high-throughput automated assays utilizing liquid handler robots

  • Strong individual contributor as well as dedicated team player

  • Experience designing and executing studies including stability, guard banding, reproducibility and repeatability and QC method development

  • Experience working in a regulated laboratory environment under CLIA/CAP

  • Data analysis (JMP and Excel) required, coding skills (Python or R), and liquid handler programming experience are a plus

  • Excellent communication, organizational, record-keeping, planning, attention to detail and time management skills

  • Ability to manage multiple priorities in a fast-paced, dynamic environment and to collaborate cross-functionally with other groups (regulatory affairs, CLIA, LIMS, lab operations QA, automation, research)

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