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Director Ivd Product Development Jobs (NOW HIRING)

Program Director Location: Onsite - Atlanta/San Diego Job Overview: We are seeking a highly skilled ... IVD) and broader diagnostics portfolio. This role will oversee complex product development ...

Program Director Location: Onsite - Atlanta/San Diego Job Overview: We are seeking a highly skilled ... IVD) and broader diagnostics portfolio. This role will oversee complex product development ...

... 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 ...

... 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 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 ...

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Director Ivd Product Development information

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$73K

$163.7K

$244.5K

How much do director ivd product development jobs pay per year?

As of Jul 17, 2026, the average yearly pay for director ivd product development in the United States is $163,684.00, according to ZipRecruiter salary data. Most workers in this role earn between $131,500.00 and $185,500.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Director of IVD Product Development, and why are they important?

To thrive as a Director of IVD Product Development, you need deep expertise in in vitro diagnostics, product lifecycle management, and regulatory requirements, usually supported by an advanced degree in a scientific or engineering field. Familiarity with product development tools, quality management systems (such as ISO 13485), and regulatory submission platforms (like FDA or CE Mark processes) is essential. Strong leadership, strategic thinking, and cross-functional communication skills help drive innovation and align multidisciplinary teams. These skills ensure the successful development and launch of compliant, high-quality diagnostic products that meet market and regulatory demands.

What are some common challenges faced by a Director of IVD Product Development and how can they be addressed?

A Director of IVD Product Development often encounters challenges such as navigating complex regulatory requirements, aligning cross-functional teams, and managing tight project timelines. Successfully addressing these challenges requires staying up-to-date with evolving regulations (e.g., FDA, CE marking), fostering clear communication among R&D, regulatory, and marketing teams, and implementing robust project management practices. Building strong relationships with stakeholders and encouraging a culture of transparency can help to anticipate risks early and keep product development on track.

What is the difference between Director Ivd Product Development vs Product Manager Ivd?

AspectDirector Ivd Product DevelopmentProduct Manager Ivd
ResponsibilitiesOversees entire product development teams, strategic planning, and long-term product visionManages specific product features, coordinates cross-functional teams, and executes product plans
Required CredentialsTypically requires advanced degrees and extensive industry experienceOften requires a bachelor's or master's degree with relevant experience
Work EnvironmentLeadership role within R&D or product development departments in medical device companiesCollaborates across engineering, marketing, and regulatory teams in similar settings

The main difference is that the Director Ivd Product Development focuses on strategic leadership and overseeing the entire product development process, while the Product Manager Ivd handles day-to-day product planning and execution. Both roles require industry-specific knowledge and collaboration across teams, but the director has a broader scope and higher level of responsibility.

What does a Director of IVD Product Development do?

A Director of IVD (In Vitro Diagnostics) Product Development leads teams responsible for creating and improving diagnostic devices and assays used in laboratory testing of biological samples. They oversee the entire product development process, from concept through design, testing, regulatory approval, and market launch. Their role involves strategic planning, cross-functional collaboration, ensuring compliance with regulatory standards, and managing timelines and budgets. Directors in this field play a critical role in bringing innovative diagnostic products to market that improve patient care.
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Program Director

Program Director

CorDx

Atlanta, GA • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 18 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 diseases 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 Type: Full time

Job Title: Program Director

Location: Onsite - Atlanta/San Diego

Job Overview:

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 complex product development initiatives from concept through commercialization, ensuring alignment with strategic objectives, regulatory compliance, and time/cost constraints. The ideal candidate will have a strong background in project/program management, deep understanding of the biotech/IVD landscape, and a proven track record in delivering results through collaboration and leadership.

Key Responsibilities:

  • Lead cross-functional program teams across R&D, Regulatory Affairs, Clinical, Quality, Operations, and Commercial to deliver IVD/diagnostic products from feasibility to launch.
  • Develop and manage detailed program plans, timelines, budgets, and resource allocation.
  • Serve as the primary point of contact for program status, risk assessment, and issue resolution.
  • Drive strategic alignment across stakeholders and ensure program goals are met in accordance with company objectives.
  • Track key milestones and prepare executive-level reporting on program performance and progress.
  • Facilitate effective communication across internal teams, senior leadership, and external partners.
  • Ensure programs meet regulatory requirements (e.g., FDA, ISO 13485) and support submission readiness.
  • Manage program governance, including steering committee meetings and stage gate reviews.
  • Identify risks and proactively implement mitigation strategies to ensure timelines and deliverables are met.

Requirements

Qualifications:

  • Bachelor’s degree in Life Sciences, Engineering, or a related field; advanced degree (MS, PhD, or MBA) preferred.
  • 8-10+ years of experience in the biotech, diagnostics, or medical device industry, with a focus on IVD product development.
  • 5+ years of program/project management experience in a regulated environment.
  • Strong knowledge of regulatory pathways, quality systems (e.g., ISO 13485), and clinical development for IVDs.
  • Proven ability to lead cross-functional teams and manage complex programs with multiple stakeholders.
  • Life Science/ IVD industry experience preferred.
  • PMP certification or formal training in project/program management strongly preferred.
  • Excellent communication, leadership, and organizational skills.
  • Comfortable in a fast-paced organization with evolving priorities.

Preferred Skills & Competencies:

  • Experience with global product launches and managing distributed teams.
  • Familiarity with Agile and/or Stage-Gate development methodologies.
  • Prior experience working with external partners and managing outsourced development/manufacturing.
  • Strong problem-solving skills and business acumen.

Benefits

  • Comprehensive medical, dental, and vision insurance.
  • 401(k) plan with generous company contributions.
  • Flexible paid time off (PTO) policy.
  • Additional substantial benefits.

Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.