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Ivd Product Development Jobs (NOW HIRING)

CorDx

Regulatory Manager- IVD and 510(k)

San Diego, CA · On-site

$90K - $150K/yr

... 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 ...

CorDx

Regulatory Manager- IVD and 510(k)

San Diego, CA

$90K - $150K/yr

Regulatory Manager - IVD and 510(K) Location: Onsite - San Diego Salary Range: $90000-$150000 ... Provide regulatory guidance on product development projects to ensure compliance from concept to ...

Quanterix

Sr. Director, Assay Development

Billerica, MA · On-site

$225K - $265K/yr

Experience supporting regulated IVD products under EU IVDR and/or FDA frameworks, including ... Experience of successfully leading development of products within a stage-gate process is required.

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

$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 ...

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All JobsIvd Product Development Jobs

Ivd Product Development information

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$42.5K

$127K

$144.5K

How much do ivd product development jobs pay per year?

As of Jun 11, 2026, the average yearly pay for ivd product development in the United States is $126,987.00, according to ZipRecruiter salary data. Most workers in this role earn between $114,500.00 and $143,000.00 per year, depending on experience, location, and employer.

What is the difference between Ivd Product Development vs Ivd Quality Assurance?

AspectIvd Product DevelopmentIvd Quality Assurance
Primary FocusDesigning and developing in vitro diagnostic productsEnsuring the quality and compliance of IVD products
Required CredentialsEngineering or scientific degrees, regulatory knowledgeQuality management certifications, regulatory standards familiarity
Work EnvironmentResearch labs, product design teamsQuality labs, regulatory compliance departments
Industry UsageProduct creation and innovationProduct validation, testing, and compliance assurance

While Ivd Product Development focuses on creating and designing new diagnostic products, Ivd Quality Assurance ensures these products meet quality standards and regulatory requirements. Both roles are essential in bringing safe and effective IVD products to market, often working closely throughout the product lifecycle.

What are the most commonly searched types of Ivd Product Development jobs? The most popular types of Ivd Product Development jobs are:
Infographic showing various Ivd Product Development job openings in the United States as of June 2026, with employment types broken down into 79% Full Time, 17% Part Time, and 4% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $126,987 per year, or $61.1 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.

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