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Ivd Project Manager Jobs (NOW HIRING)

CorDx

Regulatory Manager- IVD and 510(k)

San Diego, CA · On-site

$90K - $150K/yr

Regulatory Manager - IVD and 510(K) Location: Onsite - San Diego Salary Range: $90000-$150000 ... projects to ensure compliance from concept to commercialization. · Review and provide input on ...

Roche

Regulatory Affairs Project Manager

Branchburg, NJ · On-site +1

$84K - $157K/yr

IVD device experience is preferred. * Can manage high-complexity work and/or global projects, or equivalent experience. Additional Preferred Experience: * Experience with international regulatory ...

Roche

Regulatory Affairs Project Manager

Tucson, AZ · On-site +1

$84K - $157K/yr

IVD device experience is preferred. * Can manage high-complexity work and/or global projects, or equivalent experience. Additional Preferred Experience: * Experience with international regulatory ...

Roche

Regulatory Affairs Project Manager

Indianapolis, IN · On-site +1

$84K - $157K/yr

IVD device experience is preferred. * Can manage high-complexity work and/or global projects, or equivalent experience. Additional Preferred Experience: * Experience with international regulatory ...

Nova Biomedical

Project Manager II

Waltham, MA · On-site

The Project Manager II operates independently within PMO standards, defines scope and schedule, and ... Biotech, pharma, clinical, lab, or IVD experience is also acceptable. * Working knowledge of GxP ...

Nova Biomedical

Project Manager II

Waltham, MA · On-site

The Project Manager II operates independently within PMO standards, defines scope and schedule, and ... Biotech, pharma, clinical, lab, or IVD experience is also acceptable. * Working knowledge of GxP ...

TRIUM Clinical Consulting NV

... projects. * Build a meaningful career : This is a role with ownership,allowing you to leave your ... Drive strategic account management and long-term partnership development : You are not hunting for ...

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As of Sep 10, 2026, the average yearly pay for ivd project manager in the United States is $96,560.00, according to ZipRecruiter salary data. Most workers in this role earn between $75,000.00 and $113,000.00 per year, depending on experience, location, and employer.

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Infographic showing various Ivd Project Manager job openings in the United States as of June 2026, with employment types broken down into 92% Full Time, and 8% Part Time. Highlights an 80% Physical, 2% Hybrid, and 18% Remote job distribution, with an average salary of $96,560 per year, or $46.4 per hour.

Regulatory Manager- IVD and 510(k)

San Diego, CA • On-site

CorDx
Biotechnology Research and Development • 1 - 5K employees
Learn more about CorDxexternal

$90K - $150K/yr

Full-time

Medical, Retirement, PTO

Re-posted 24 days ago

Key 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.

  • Liaise with internal departments to gather necessary documentation and data for regulatory submissions.

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.