Analytical Chemist &ndash
Des Plaines, IL · On-site
Knowledge of design control and risk management in the context of IVD product development. * Prior experience supporting 510(k) or PMA submissions is a plus
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Des Plaines, IL · On-site
Knowledge of design control and risk management in the context of IVD product development. * Prior experience supporting 510(k) or PMA submissions is a plus
Quick apply
Des Plaines, IL · On-site
Knowledge of design control and risk management in the context of IVD product development. * Prior experience supporting 510(k) or PMA submissions is a plus
... Diagnostic (IVD) Next-Generation Sequencing (NGS) assays from R&D to Operations. This role is ... Investigate product or process deviations, perform root cause analysis, and implement Corrective ...
... Diagnostic (IVD) Next-Generation Sequencing (NGS) assays from R&D to Operations. This role is ... Investigate product or process deviations, perform root cause analysis, and implement Corrective ...
Prepare and manufacture buffers and reagents under controlled processes to support IVD product development and commercial manufacturing * Execute batch production with full traceability, including ...
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Prepare and manufacture buffers and reagents under controlled processes to support IVD product development and commercial manufacturing * Execute batch production with full traceability, including ...
Prepare and manufacture buffers and reagents under controlled processes to support IVD product development and commercial manufacturing * Execute batch production with full traceability, including ...
Prepare and manufacture buffers and reagents under controlled processes to support IVD product development and commercial manufacturing * Execute batch production with full traceability, including ...
Prepare and manufacture buffers and reagents under controlled processes to support IVD product development and commercial manufacturing * Execute batch production with full traceability, including ...
Prepare and manufacture buffers and reagents under controlled processes to support IVD product development and commercial manufacturing * Execute batch production with full traceability, including ...
... required for IVD product registration, , and solve and coordinate the difficult problems ... development process of various technology platforms within the company * Product life cycle ...
Quick apply
... required for IVD product registration, , and solve and coordinate the difficult problems ... development process of various technology platforms within the company * Product life cycle ...
$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.
$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.
Palo Alto, CA · On-site
$260 - $320/hr
Interact with FDA on IVD product submissions, including meetings and written presubmissions. * Author relevant sections of IVD documents related to clinical development, design controls, and ...
Palo Alto, CA · On-site
$260 - $320/hr
Interact with FDA on IVD product submissions, including meetings and written presubmissions. * Author relevant sections of IVD documents related to clinical development, design controls, and ...
Palo Alto, CA · On-site
$260 - $320/hr
About this Role The Sr. Director, Clinical Development provides leadership across DELFI's clinical ... Interact with FDA on submissions for IVD product approval, including face-to-face/virtual meetings ...
New
Palo Alto, CA · On-site
$260 - $320/hr
About this Role The Sr. Director, Clinical Development provides leadership across DELFI's clinical ... Interact with FDA on submissions for IVD product approval, including face-to-face/virtual meetings ...
New
Billerica, MA · On-site
$225K - $265K/yr
Sr Director, Assay Development Billerica, MA Quanterix is a global leader in ultra-sensitive ... Experience supporting regulated IVD products under EU IVDR and/or FDA frameworks, including ...
Billerica, MA · On-site
$225K - $265K/yr
Sr Director, Assay Development Billerica, MA Quanterix is a global leader in ultra-sensitive ... Experience supporting regulated IVD products under EU IVDR and/or FDA frameworks, including ...
Strong knowledge of IVD product development lifecycle, including design controls, verification & validation, and regulatory submissions (FDA, IVDR) * Experience working in cross-functional ...
Strong knowledge of IVD product development lifecycle, including design controls, verification & validation, and regulatory submissions (FDA, IVDR) * Experience working in cross-functional ...
$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 ...
$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 ...
Experience in medical device or IVD product development and testing Knowledge of CAN communication and wired communication protocols Familiarity with Engineering Change (EC) processes Experience with ...
New
Experience in medical device or IVD product development and testing Knowledge of CAN communication and wired communication protocols Familiarity with Engineering Change (EC) processes Experience with ...
New
Strong knowledge of IVD product development lifecycle, including design controls, verification & validation, and regulatory submissions (FDA, IVDR) * Experience working in cross-functional ...
Strong knowledge of IVD product development lifecycle, including design controls, verification & validation, and regulatory submissions (FDA, IVDR) * Experience working in cross-functional ...
The Sr Mgr, Quality Design Assurance owns endtoend quality for FMI's regulated medical devices and IVD development processes. Partnering closely with Product Development, Regulatory Affairs, Quality ...
The Sr Mgr, Quality Design Assurance owns endtoend quality for FMI's regulated medical devices and IVD development processes. Partnering closely with Product Development, Regulatory Affairs, Quality ...
Hazelwood, MO · On-site
$132 - $180/hr
Strong knowledge of IVD product development lifecycle, including design controls, verification & validation, and regulatory submissions (FDA, IVDR) * Experience working in cross-functional ...
New
Hazelwood, MO · On-site
$132 - $180/hr
Strong knowledge of IVD product development lifecycle, including design controls, verification & validation, and regulatory submissions (FDA, IVDR) * Experience working in cross-functional ...
New
Strong knowledge of IVD product development lifecycle, including design controls, verification & validation, and regulatory submissions (FDA, IVDR) * Experience working in cross-functional ...
Strong knowledge of IVD product development lifecycle, including design controls, verification & validation, and regulatory submissions (FDA, IVDR) * Experience working in cross-functional ...
Strong knowledge of IVD product development lifecycle, including design controls, verification & validation, and regulatory submissions (FDA, IVDR) * Experience working in cross-functional ...
Strong knowledge of IVD product development lifecycle, including design controls, verification & validation, and regulatory submissions (FDA, IVDR) * Experience working in cross-functional ...
Waltham, MA · Hybrid
$120K - $160K/yr
Participate in internal and external audits, providing subject matter expertise on design controls and IVD product development. Experience Requirements: * Bachelors degree in Engineering, Life ...
Waltham, MA · Hybrid
$120K - $160K/yr
Participate in internal and external audits, providing subject matter expertise on design controls and IVD product development. Experience Requirements: * Bachelors degree in Engineering, Life ...
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 ...
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 ...
$42.5K - $51.8K
1% of jobs
$51.8K - $61K
0% of jobs
$61K - $70.3K
2% of jobs
$70.3K - $79.6K
3% of jobs
$79.6K - $88.9K
4% of jobs
$88.9K - $98.1K
4% of jobs
$98.1K - $107.4K
4% of jobs
$113.8K is the 25th percentile. Wages below this are outliers.
$107.4K - $116.7K
9% of jobs
$116.7K - $126K
6% of jobs
$126K - $135.2K
2% of jobs
The median wage is $137.2K / yr.
$135.2K - $144.5K
64% of jobs
$42.5K
$127K
$144.5K
| Aspect | Ivd Product Development | Ivd Quality Assurance |
|---|---|---|
| Primary Focus | Designing and developing in vitro diagnostic products | Ensuring the quality and compliance of IVD products |
| Required Credentials | Engineering or scientific degrees, regulatory knowledge | Quality management certifications, regulatory standards familiarity |
| Work Environment | Research labs, product design teams | Quality labs, regulatory compliance departments |
| Industry Usage | Product creation and innovation | Product 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.

Contractor
Re-posted 17 days ago
Sourced by ZipRecruiter
Software development
51 - 200 Employees
Irving, TX, US
2019