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Ivd In Vitro Diagnostics Jobs (NOW HIRING)

Qiagen

Senior Scientific Expert IVD

Germantown, MD

$82K - $137K/yr

The ideal candidate will have experience in developing in vitro diagnostic (IVD) products in a regulated environment. A strong background in immunology/molecular biology is critical. The Senior ...

Mondo

Analyst II (Post-Market Complaints)

San Diego, CA · On-site

$45 - $55/hr

Knowledge of blood gas analyzers, in vitro diagnostics (IVD), or related medical technologies. * Experience identifying process improvement opportunities. * Ability to mentor or train peers on ...

DiaSorin

Production Specialist I

Stillwater, MN · On-site

$18.27 - $27.40/hr

... IVD (In Vitro Diagnostics) / Device / Pharmaceutical industry and/or highly regulated FDA environments and biotechnology / medical device fields. • Experience using basic laboratory equipment to ...

CorDx

Program Director

San Diego, CA · On-site

We are seeking a highly skilled and experienced Program Director to lead cross-functional programs within our In Vitro Diagnostics (IVD) and broader diagnostics portfolio. This role will oversee ...

CorDx

Program Director

Atlanta, GA · On-site

We are seeking a highly skilled and experienced Program Director to lead cross-functional programs within our In Vitro Diagnostics (IVD) and broader diagnostics portfolio. This role will oversee ...

CorDx

Program Director

San Diego, CA · On-site

We are seeking a highly skilled and experienced Program Director to lead cross-functional programs within our In Vitro Diagnostics (IVD) and broader diagnostics portfolio. This role will oversee ...

Danaher

Senior Clinical Study Manager

In this role, you will have the opportunity to: * Provide strategic oversight into the operational planning and execution of complex programs and individual In Vitro Diagnostics (IVD) clinical ...

DiaSorin

Production Specialist I

Stillwater, MN · On-site

$18.27 - $27.40/hr

Manufacturing experience, preferably with liquid filing, in IVD (In Vitro Diagnostics) / Device / Pharmaceutical industry and/or highly regulated FDA environments and biotechnology / medical device ...

Axiom Talent Platform

OR

$309K/yr

We are seeking an experienced FDA Regulatory Attorney with deep, hands-on expertise in Class III PMA in vitro diagnostic (IVD) and companion diagnostic products to work with our client, a Fortune 500 ...

CorDx

Program Director

Atlanta, GA · On-site

We are seeking a highly skilled and experienced Program Director to lead cross-functional programs within our In Vitro Diagnostics (IVD) and broader diagnostics portfolio. This role will oversee ...

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All JobsIvd In Vitro Diagnostics Jobs

Ivd In Vitro Diagnostics information

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

As of Jul 25, 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.
More about Ivd In Vitro Diagnostics jobs
What cities are hiring for Ivd In Vitro Diagnostics jobs? Cities with the most Ivd In Vitro Diagnostics job openings:
What states have the most Ivd In Vitro Diagnostics jobs? States with the most job openings for Ivd In Vitro Diagnostics jobs include:
What job categories do people searching Ivd In Vitro Diagnostics jobs look for? The top searched job categories for Ivd In Vitro Diagnostics jobs are:
Ivd In Vitro Diagnostics jobs near you
Infographic showing various Ivd In Vitro Diagnostics job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 91% Full Time, 5% Part Time, 2% Contract, and 1% Summer. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution, with an average salary of $107,970 per year, or $51.9 per hour.
Manager - Regulatory Affairs (Remote)

Manager - Regulatory Affairs (Remote)

Caris Life Sciences

Remote

$124K - $152K/yr

Full-time

Posted 20 days ago

Job description

At Caris, we understand that cancer is an ugly word-a word no one wants to hear, but one that connects us all. That's why we're not just transforming cancer care-we're changing lives.
We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: "What would I do if this patient were my mom?" That question drives everything we do.
But our mission doesn't stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare-driven by innovation, compassion, and purpose.
Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins.
Position Summary
The Manager - Regulatory Affairs is responsible for regulatory activities related to in vitro diagnostic projects and applicable submissions. This position will have a variety of responsibilities to include preparation of regulatory documents, reviewing for regulatory compliance and monitoring of new guidance from various regulatory agencies.
Job Responsibilities
  • Lead as the RA representative on project core teams providing active and successful regulatory guidance and RA strategies.
  • Independently review changes in products, product specifications, and manufacturing processes to assess regulatory implications of the change.
  • Prepares documents necessary for new product market clearance, approval, and continuance during product life cycle management that includes, but not limited to, 510Ks, IDEs, supplements, and technical files for CE marketing.
  • Lead pharmaceutical partner interactions on new and sustaining projects including regulatory strategy and pre-submissions.
  • Review and provide regulatory input on analytical and clinical study protocols.
  • Provide support, as needed, for FDA inspections, Pre-Approval Inspections or European Notified Body Inspections.
  • Provide guidance to pharmaceutical partners and junior regulatory staff regarding regulatory requirements including indications of risk and approximate timing for approval for planning purposes.
  • Ensure regulatory compliance with relevant regulations and effectively managing timely submissions to the appropriate regulatory authorities.
  • Support compliance activities associated with the Quality Management System to fulfill with international and domestic policies and regulations.

Required Qualifications
  • Bachelor's degree in a science-related area of study.
  • Minimum of 6 years hands-on submission experience including the developing and execution of regulatory strategies for medical device and/or IVD regulated products.
  • Must have knowledge of U.S and European product submission and registration requirements for medical devices and/or IVD regulated products.
  • Strong understanding of product development process, design controls, and ability to effectively partner cross-functionally to develop and influence sound strategies.
  • Ability to work independently, taking ownership for the management of processes, projects, and timelines.
  • Proficient with MS Office computer programs, including Word, Power Point, Excel, Visio, Outlook and Project.

Preferred Qualifications
  • Master's degree in a science-related area of study.
  • Prior experience with in vitro diagnostics.
  • Demonstrate in-depth understanding of sophisticated technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
  • Experience leading and/or supporting US FDA submissions.
  • Experience in writing/maintaining CE Technical Files.
  • Ability to mentor and lead others through challenging circumstances.

Physical Demands
  • Employee may be required to lift routine office supplies and use standard office equipment.
  • Ability to sit/stand for extended periods of time while using a computer.

Training
  • All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.

Other
  • This position may require periodic travel and some evenings, weekends and/or holidays.

Annual Hiring Range
$124,000.00 - $152,000.00
Actual compensation offer to candidate may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level. The pay ratio between base pay and target incentive (if applicable) will be finalized at offer.
Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.
This job description reflects management's assignment of essential functions. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.
Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

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