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Ivd In Vitro Diagnostics Jobs (NOW HIRING)

CorDx

Regulatory Manager- IVD and 510(k)

San Diego, CA · On-site

$90K - $150K/yr

The ideal candidate will have a strong background in IVD (In Vitro Diagnostics) and experience with 510(k) preparation and submissions to ensure compliance with FDA and other regulatory body ...

CorDx

Regulatory Manager- IVD and 510(k)

San Diego, CA · On-site

$90K - $150K/yr

The ideal candidate will have a strong background in IVD (In Vitro Diagnostics) and experience with 510(k) preparation and submissions to ensure compliance with FDA and other regulatory body ...

CorDx

Regulatory Manager- IVD and 510(k)

San Diego, CA

$90K - $150K/yr

The ideal candidate will have a strong background in IVD (In Vitro Diagnostics) and experience with 510(k) preparation and submissions to ensure compliance with FDA and other regulatory body ...

Predicine, Inc

Head of Manufacturing

Hayward, CA · On-site

Head of Manufacturing - In Vitro Diagnostics (IVD) / Molecular Diagnostics / NGS Full-Time | Onsite Overview We are seeking a seasoned Head of Manufacturing to lead end-to-end manufacturing ...

CorDx

Regulatory & Compliance Specialist

San Diego, CA · On-site

$90K - $95K/yr

The Quality and Regulatory Compliance Specialist is responsible for ensuring that development processes for all in vitro diagnostic (IVD) products comply with applicable regulatory requirements and ...

CorDx

Regulatory & Compliance Specialist

San Diego, CA · On-site

$90K - $95K/yr

The Quality and Regulatory Compliance Specialist is responsible for ensuring that development processes for all in vitro diagnostic (IVD) products comply with applicable regulatory requirements and ...

CorDx

Regulatory & Compliance Specialist

San Diego, CA · On-site

$90K - $95K/yr

The Quality and Regulatory Compliance Specialist is responsible for ensuring that development processes for all in vitro diagnostic (IVD) products comply with applicable regulatory requirements and ...

CorDx

Quality Manager

Atlanta, GA · On-site

Onsite - Atlanta Office We are seeking an experienced Quality Manager to join our team in the IVD (In Vitro Diagnostic) industry. The ideal candidate will have a minimum of 10 years of relevant ...

CorDx

Quality Manager

Atlanta, GA · On-site

Onsite - Atlanta Office We are seeking an experienced Quality Manager to join our team in the IVD (In Vitro Diagnostic) industry. The ideal candidate will have a minimum of 10 years of relevant ...

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Ivd In Vitro Diagnostics information

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How much do ivd in vitro diagnostics jobs pay per year?

As of Jun 10, 2026, the average yearly pay for ivd in vitro diagnostics in the United States is $107,970.00, according to ZipRecruiter salary data. Most workers in this role earn between $75,500.00 and $150,500.00 per year, depending on experience, location, and employer.

What is the difference between Ivd In Vitro Diagnostics vs Medical Laboratory Technician?

AspectIvd In Vitro DiagnosticsMedical Laboratory Technician
CredentialsTypically requires certification in IVD or related fields, such as CLIA certificationRequires an associate degree in medical laboratory technology and certification
Work EnvironmentManufacturing settings, quality control labs, or clinical laboratoriesHospital, diagnostic labs, or clinics
Industry UsageDesign, manufacturing, and quality assurance of diagnostic devicesPerforming tests, analyzing samples, and reporting results

Both roles are essential in the healthcare industry but focus on different aspects. Ivd In Vitro Diagnostics professionals mainly work in manufacturing and quality assurance of diagnostic tools, while Medical Laboratory Technicians perform testing and analysis in clinical settings. Understanding these differences helps clarify career paths and job expectations in the diagnostics industry.

What are the key skills and qualifications needed to thrive as an In Vitro Diagnostics (IVD) Specialist, and why are they important?

To thrive as an In Vitro Diagnostics (IVD) Specialist, you need a solid background in life sciences, laboratory techniques, and often a degree in biology, chemistry, biomedical engineering, or a related field. Familiarity with diagnostic instruments, laboratory information management systems (LIMS), and relevant regulatory certifications such as ISO 13485 or CLIA compliance is typically required. Strong analytical thinking, attention to detail, and effective communication are crucial soft skills for interpreting results and collaborating with healthcare professionals. These competencies ensure the accuracy and reliability of diagnostic testing, which is essential for patient care and regulatory compliance.

What are In Vitro Diagnostics (IVD)?

In Vitro Diagnostics (IVD) are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. These tests help detect diseases, conditions, or infections and are used in medical laboratories, hospitals, and even at home. IVD devices include things like blood glucose monitors, pregnancy tests, and COVID-19 test kits. They play a critical role in disease prevention, diagnosis, and monitoring treatment effectiveness.

What are some typical challenges faced by professionals working in In Vitro Diagnostics (IVD) roles?

Professionals in IVD often face challenges related to ensuring regulatory compliance, as the industry is highly regulated and standards can change frequently. Additionally, staying updated with rapid technological advancements and integrating new testing methodologies into existing workflows can be demanding. Collaboration across multidisciplinary teams—scientists, quality assurance, regulatory, and manufacturing—is essential, and effective communication is key to navigating complex projects. Balancing the need for innovation with strict quality and safety requirements is also a common challenge in this field.
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What cities are hiring for Ivd In Vitro Diagnostics jobs? Cities with the most Ivd In Vitro Diagnostics job openings:
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Ivd In Vitro Diagnostics jobs near you
Infographic showing various Ivd In Vitro Diagnostics job openings in the United States as of June 2026, with employment types broken down into 76% Locum Tenens, 2% As Needed, 7% Full Time, 7% Contract, 1% Nights, and 7% Summer. Highlights an 94% Physical, 1% Hybrid, and 5% Remote job distribution, with an average salary of $107,970 per year, or $51.9 per hour.
Regulatory Manager- IVD and 510(k)

Regulatory Manager- IVD and 510(k)

CorDx

San Diego, CA • On-site

$90K - $150K/yr

Full-time

Medical, Retirement, PTO

Posted 22 days ago

Job description

Who is CorDx？

CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.
Job Description

We are seeking a highly motivated and experienced Regulatory Specialist to join our Regulatory Affairs team. The ideal candidate will have a strong background in IVD (In Vitro Diagnostics) and experience with 510(k) preparation and submissions to ensure compliance with FDA and other regulatory body requirements.

Job Type: Full time
Job Title: Regulatory Manager - IVD and 510(K)
Location: 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 submission processes, including documentation, timelines, and communication with regulatory bodies, as needed.

· Conduct regulatory risk assessments and develop mitigation strategies for IVD products.

· Stay updated with regulatory changes and ensure all IVD products comply with current regulations.

· Liaise with internal departments (R&D, Quality, Manufacturing) to gather necessary documentation and data for regulatory submissions.

· Provide regulatory guidance on product development projects to ensure compliance from concept to commercialization.

· Review and provide input on product labeling, promotional materials, and change controls to ensure regulatory compliance.

· Assist in the development and implementation of regulatory strategies and update stakeholders on regulatory developments affecting the company’s products.

Requirements

· Bachelor’s degree in Life Sciences, Biotechnology, Regulatory Affairs, or a related field.

· Minimum of 5 years of experience in relevant industry with min or 3 year hands on experience in 510(k) preparations and submissions.

· Strong understanding of FDA regulations, guidance documents, and processes related to IVD products.

· Experience in interacting with regulatory agencies, particularly the FDA.

· Excellent analytical, organizational, and communication skills.

· Detail-oriented with the ability to manage multiple projects simultaneously.
Preferred Skills

RAC certification or similar.

Benefits

    • Health Care Plan (Medical)
    • 401K
    • Paid Time Off and Paid Sick Leave
    • Training & Development

We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.